natgillin/translations-raw huggingface dataset:
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.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.
Cholestagel kot monoterapija je indiciran kot dodatno zdravljenje ob dieti za zniževanje zvišanega celokupnega holesterola in holesterola LDL (LDL- C) pri odraslih bolnikih z izolirano primarno hiperholesterolemijo, za katere se smatra, da statin ni ustrezen ali ga slabo prenašajo.
Posology Combination therapy
Kombinirano zdravljenje
The recommended dose of Cholestagel is 4 to 6 tablets per day.
Priporočeni odmerek zdravila Cholestagel je od 4 do 6 tablet dnevno.
The maximum recommended dose is 3 tablets taken twice per day with meals or 6 tablets taken once per day with a meal.
Najvišji priporočeni odmerek je 3 tablete dvakrat dnevno, ob obrokih, ali 6 tablet enkrat dnevno, ob obroku.
Clinical trials have shown that Cholestagel and atorvastatin, lovastatin or simvastatin can be co-administered or dosed apart.
Klinična preskušanja so pokazala, da se lahko zdravilo Cholestagel jemlje skupaj ali ločeno z atorvastatinom, lovastatinom ali simvastatinom.
Monotherapy The recommended starting dose of Cholestagel is 3 tablets taken twice per day with meals or 6 tablets once per day with a meal.
Samostojno zdravljenje Priporočeni začetni odmerek je 3 tablete dvakrat dnevno, ob obrokih, ali 6 tablet enkrat dnevno, ob obroku.
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.
When a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered 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, je potrebno zdravilo Cholestagel vzeti vsaj štiri ure po sočasno uporabljenem zdravilu, da bi zmanjšali tveganje zmanjšane absorpcije sočasno uporabljenega zdravila (glejte poglavje 4. 5).
Elderly population There is no need for dose adjustment when Cholestagel is administered to elderly patients.
Pri uporabi zdravila Cholestagel pri starejših bolnikih ni potrebno prilagoditi odmerka.
2 Paediatric population The safety and efficacy of Cholestagel have not been established in children and adolescent patients; therefore, the use of Cholestagel in these patient populations is not recommended.
2 Pediatrični bolniki U
Method of administration Cholestagel tablets should be taken orally with a meal and liquid.
Tablete Cholestagel je treba jemati peroralno s tekočino in ob obroku.
• Hypersensitivity to the active substance or to any of the excipients • Bowel or biliary obstruction
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, • zapora črevesa ali žolča.
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.
For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin:
Za bolnike, ki jemljejo ciklosporin in bodo začeli jemati ali prenehali jemati zdravilo Cholestagel, ali za bolnike, ki jemljejo zdravilo Cholestagel in morajo začeti jemati tudi ciklosporin:
Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5).
Zdravilo Cholestagel zmanjša biološko uporabnost ciklosporina (glejte tudi poglavje 4. 5). Bolniki, ki že jemljejo zdravilo Cholestagel in bodo hkrati začeli jemati ciklosporin, morajo imeti kontrolne izmerjene vrednosti ciklosporina v krvi normalne in odmerek ciklosporina prilagojen normalni vrednosti.
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.
Safety and efficacy are not established for patients with triglyceride levels greater than 3.4 mmol/ L, since such patients were excluded from the clinical studies.
Varnost in učinkovitost uporabe še nista potrjeni pri bolnikih, ki imajo koncentracije trigliceridov nad 3, 4 mmol/ L, ker so bili taki bolniki izključeni iz kliničnih študij.
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).
Pri bolnikih, ki prejemajo varfarin ali podobne učinkovine, morate zdravljenje z antikoagulanti pozorno spremljati, kajti adsorbenti žolčnih kislin, kot je zdravilo Cholestagel, zmanjšujejo absorpcijo vitamina K in tako ovirajo antikoagulantni učinek varfarina (glejte tudi poglavje 4. 5).
It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5).
Pomembno je zagotoviti, da se zdravilo Cholestagel vzame najmanj 4 ure po jemanju peroralnih kontracepcijskih tabletk za zmanjšanje tveganja kakršnegakoli medsebojnega vplivanja (glejte tudi poglavje 4. 5).
In general Cholestagel may affect the bioavailability of other medicinal products.
Splošno Zdravilo Cholestagel lahko vpliva na biološko uporabnost drugih zdravil.
3 administered at least four hours after the concomitant medication to minimize the risk of reduced absorption of the concomitant medication
Kadar ne morete izključiti medsebojnega delovanja s sočasno uporabljenim zdravilom, je potrebno zdravilo Cholestagel vzeti najmanj štiri ure po sočasno uporabljenem zdravilu, da bi zmanjšali tveganje za zmanjšano absorpcijo sočasno uporabljenega zdravila.
Interaction studies have only been performed in adults.
Klinične raziskave medsebojnega delovanja so bile izvedene samo pri odraslih.
Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
B
Anticoagulant therapy Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect.
Zdravljenje z antikoagulanti Pri bolnikih, ki prejemajo varfarin ali podobna zdravila, morate zdravljenje z antikoagulanti pozorno spremljati, kajti adsorbenti žolčnih kislin zmanjšujejo absorpcijo vitamina K in tako ovirajo antikoagulatni učinek varfarina.
Levothyroxine In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour.
Niso opazili medsebojnega B
No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
delovanja, če je bilo zdravilo Cholestagel vzeto najmanj štiri ure po levotiroksinu.
Oral contraceptive pill 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.
Peroralna kontracepcijska tabletka V študiji o medsebojnem delovanju pri zdravih prostovoljcih je zdravilo Cholestagel znižalo vrednosti CBmax noretindrona ter vrednosti AUC in CBmax etinilestradiola ob sočasnem jemanju s peroralno
However no interaction was observed when Cholestagel was administered four hours after the oral contraceptive pill.
Tako medsebojno delovanje so opazili tudi, če je bilo zdravilo Cholestagel vzeto eno uro po peroralni kontracepcijski tabletki, vendar pa niso opazili medsebojnega delovanja, če je bilo zdravilo Cholestagel vzeto štiri ure po peroralni kontracepcijski tabletki.
Ciclosporin 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.
Ciklosporin V klinični raziskavi medsebojnega delovanja pri zdravih prostovoljcih je sočasno jemanje zdravila Cholestagel in ciklosporina znatno znižalo vrednosti AUCB0- inf ciklosporina za 34% in vrednosti CBmax
Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4).
Svetujemo, da pozorno nadzorujete vrednosti ciklosporina v krvi (glejte tudi poglavje 4. 4).
Statins 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.
Statini 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.
Interaction studies with colesevelam in combination with pravastatin, rosuvastatin, or high dose HMG-CoA reductase inhibitors have not been performed.
Študije medsebojnega delovanja med holesevelamom in pravastatinom, rosuvastatinom ali visokimi odmerki inhibitorjev reduktaze HMG- CoA niso bile izvedene.
Antidiabetic agents 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.
Niso opazili medsebojnega
No interaction was observed when Cholestagel was administered four hours after glyburide.
delovanja, če je bilo zdravilo Cholestagel vzeto najmanj štiri ure po gliburidu.
4 Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown.
Sočasno jemanje zdravil Cholestagel in repaglinid ni imelo nobenega vpliva na vrednosti AUC, povzročilo pa je znižanje vrednosti CBmax repaglinida za 19%, vendar pa klinična pomembnost le- tega B
Other forms of interaction Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Druge oblike medsebojnega delovanja Cholestagel ni povzročil klinično pomembnega zmanjšanja absorpcije vitaminov A, D, E ali K med kliničnimi študijami, ki so trajale do enega leta.
Pregnancy No clinical data are available on the use of Cholestagel in pregnant women.
Nosečnost Klinični podatki o uporabi zdravila Cholestagel pri nosečnicah niso na voljo.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Lactation The safety of Cholestagel has not been established in breast-feeding women.
Dojenje Varnost zdravila Cholestagel ni bila potrjena pri ženskah, ki dojijo.
Cholestagel has no or negligible influence on the ability to drive and use machines.
Cholestagel nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
In controlled clinical studies involving approximately 1400 patients, the following adverse reactions were reported in patients given Cholestagel.
V kontroliranih kliničnih študijah, v katerih je sodelovalo približno 1400 bolnikov, so poročali o naslednjih neželenih učinkih pri bolnikih, ki so prejemali zdravilo Cholestagel.
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.
Navedba pogostosti neželenih učinkov je označena kot zelo pogosto (≥1/ 10), pogosto (≥1/ 100, < 1/ 10), občasno (≥1/ 1. 000, < 1/ 100), redko (≥1/ 10. 000, < 1/ 1000), zelo redko (< 1/ 10. 000), vključno z izoliranimi primeri.
Myalgia
Preiskave Pogosto: povišana koncentracija serumskih trigliceridov Občasno: povišana koncentracija serumskih transaminaz Bolezni živčevja Pogosto: glavobol Bolezni prebavil Zelo pogosto: flatulenca, obstipacija Pogosto: bruhanje, diareja, dispepsija, bolečine v trebuhu, nenormalno blato, navzea Bolezni mišično- skeletnega sistema in vezivnega tkiva Občasno: mialgija
The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
5 V istih nadziranih kliničnih študijah so opazili večjo pogostost pojavljanja flatulence in diareje pri bolnikih, ki so prejemali placebo.
Adverse reactions were generally mild or moderate in intensity.
Jakost neželenih učinkov je bila večinoma blaga do zmerna.
5 Cholestagel in combination with statins did not result in any frequent unexpected adverse reactions compared with statins alone.
Cholestagel v kombinaciji s statini, v primerjavi z uporabo statinov samih, ni povzročil kakršnihkoli pogostih nepričakovanih neželenih učinkov.
Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Odmerkov, večjih od najvišjega priporočenega odmerka (4, 5 g dnevno (7 tablet)), niso preizkusili.
Pharmacotherapeutic group: bile acid sequestrants, ATC code:
Oznaka ATC:
C10A C 04
C10AC04
Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Veže se na žolčne kisline v črevesu in tako preprečuje njihovo ponovno absorpcijo.
The LDL-C lowering mechanism of bile acid sequestrants has been previously established as follows:
Mehanizem nižanja koncentracije holesterola LDL absorbentov žolčnih kislin deluje na naslednji način:
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.
Ko začne zmanjkovati žolčnih kislin, se poveča delovanje jetrnega encima holesterol 7- α- hidroksilaze, kar poveča pretvorbo holesterola v žolčne kisline.
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.
To povzroči povečano potrebo po holesterolu v jetrnih celicah, kar ima dvojni učinek: poveča se prepis in aktivnost encima za biosintezo holesterola, hidroksimetil- glutaril - koencima A (HMG- CoA) reduktaze, in v jetrih se poveča število receptorjev za lipoproteine nizke gostote.
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.
V šestmesečni študiji odzivnosti na odmerke pri bolnikih s primarno hiperholesterolemijo, ki so 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%.
Poleg tega se je koncentracija celokupnega holesterola znižala za 7 do 10%, koncentracija holesterola HDL se je zvišala za 3%, koncentracija trigliceridov pa za 9 do 10%.
Apo B decreased by 12%.
Koncentracija Apo B se je znižala za 12%.
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%.
However, in one study triglycerides tended to increased more when Cholestagel was given as a single dose with breakfast.
Vendar je pri eni študiji prišlo do večjega zvišanja koncentracije trigliceridov pri jemanju zdravila Cholestagel v obliki enojnega odmerka ob zajtrku.
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%.
Initiation of add-on treatment with Cholestagel subsequent to statin therapy has not been specifically studied.
Študij nadaljnjega zdravljenja z 6 zdravilom Cholestagel po zdravljenju s statini niso opravili.
The fenofibrate plus Cholestagel group (64 patients)
V 6- tedenski študiji so 129 bolnikom z mešano hiperlipidemijo naključno dajali kombinacijo 160 mg fenofibrata in 3, 8 g zdravila Cholestagel ali pa samo fenofibrat.
6 demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients).
V skupini, ki je jemala fenofibrat in zdravilo Cholestagel (64 bolnikov), je prišlo do 10% znižanja vrednosti LDL- C v primerjavi z 2% zvišanjem te vrednosti v skupini, ki je jemala samo fenofibrat (65 bolnikov).
Reductions were also seen for non-HDL-C, Total-C and Apo B.
Znižanje so opazili tudi pri vrednostih ne- HDL- C, skupnega- C in Apo B.
A small 5%, non-significant increase in triglycerides was noted.
Opazili so manjše 5% neznačilno zvišanje trigliceridov.
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.
V predkliničnih študijah so opazili učinke samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Jedro tablete: mikrokristalna celuloza (E460) brezvodni koloidni silicijev dioksid magnezijev stearat prečiščena voda
6.5 Nature and contents of container
7 6. 5 Vrsta ovojnine in vsebina
24 tablets (1 X 24) 100 tablets (2 X 50) 180 tablets (1 X 180)
24 tablet (1 x 24) 100 tablet (2 x 50) 180 tablet (1 x 180)
7 High density polyethylene bottles with a polypropylene cap without outer carton.
Plastenke iz polietilena visoke gostote s pokrovom iz polipropilena brez zunanje ovojnine.
6.6 Instructions precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
U
Α MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
9 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
9 A IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije U
OUTER CARTON AND BOTTLE LABEL (24 TABLETS)
NALEPKA NA ŠKATLI IN PLASTENKI (24 TABLET)
Cholestagel 625 mg film-coated tablets Colesevelam hydrochloride
Cholestagel 625 mg filmsko obložene tablete holesevelamijev klorid
Oral use Tablets should be taken with liquid and with a meal.
Peroralna uporaba Tablete morate jemati s tekočino in ob obroku.
Genzyme Europe B. V.
Genzyme Europe B.
Gooimeer 10 1411 DD Naarden The Netherlands
Gooimeer 10 1411 DD Naarden Nizozemska
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
14 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON AND BOTTLE LABEL (100 TABLETS)
NALEPKA NA ŠKATLI IN PLASTENKI (100 TABLET)
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
16 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON AND BOTTLE LABEL (180 TABLETS)
NALEPKA NA ŠKATLI IN PLASTENKI (180 TABLET)
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 PODATKI NA ZUNANJI OVOJNINI
BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
NALEPKA NA PLASTENKI (180 TABLET) BREZ ZUNANJE OVOJNINE
What Cholestagel is and what it is used for 2.
Kaj je zdravilo Cholestagel in za kaj ga uporabljamo 2.
Before you take Cholestagel 3.
Kaj morate vedeti, preden boste vzeli zdravilo Cholestagel 3.
How to take Cholestagel 4.
Kako jemati zdravilo Cholestagel 4.
How to store Cholestagel 6.
Shranjevanje zdravila Cholestagel 6.
WHAT CHOLESTAGEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CHOLESTAGEL IN ZA KAJ GA UPORABLJAMO
Cholestagel is prescribed to treat a condition known as isolated primary hypercholesterolaemia (when cholesterol in the blood is elevated).
Zdravilo Cholestagel se predpisuje za zdravljenje bolezni, ki ji rečemo izolirana primarna hiperholesterolemija (nenormalno zvišana koncentracija holesterola v krvi).
- Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when
- Zdravilo Cholestagel se lahko predpiše samostojno, poleg diete z nizko vsebnostjo maščob in
treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
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 may be used together with a statin and the diet low in fat and cholesterol when patients
- Zdravilo Cholestagel se lahko uporablja skupaj s statini in dieto z nizko vsebnostjo maščob in
are not appropriately controlled by the statin on its own.
holesterola, kadar zdravljenje samo s statini ne zadostuje..
BEFORE YOU TAKE CHOLESTAGEL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CHOLESTAGEL
Do not take Cholestagel
Ne jemljite zdravila Cholestagel
- if you are allergic (hypersensitive) to colesevelam or to any of the other ingredients of Cholestagel
- če ste alergični na (preobčutljivi) na holesevelam ali katerokoli sestavino zdravila Cholestagel,
- if you have a blockage in your intestines or bile ducts (tubes that carry bile)
- če imate zaporo v črevesju ali žolčevodih (vodi za izločanje žolča).
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.
Če so vam skupaj predpisali zdravilo Cholestagel in katerokoli drugo zdravilo, morate pred začetkom jemanja zdravila prebrati tudi navodilo za uporabo tega drugega zdravila.