部份中文考来维仑处方资料（仅供参考）
药品英文名
Colesevelam
药品别名
Welchol，Cholestagel
药物剂型
片剂：每片含本品625mg。
药理作用
本品是新型的降低胆固醇的药物，能与胆酸及其主要成分甘氨胆酸相结合，加速其排清，阻断其重吸收，造成胆酸耗竭，肝脏胆固醇7-α-羟化酶上调，从而增加胆固醇向胆酸的转化。
本品可以降低原发性高胆固醇血症(primary hypercholesterolemia)患者体内的低密度脂蛋白胆固醇(LDLcholesterol，LDL-ch)浓度。
临床试验结果显示，本品可以有效降低LDL-ch及总胆固醇浓度。 本品是以其非吸收性聚合体技术(non-absorbed polymer technology)为基础开发的新药，具有亲水性，为不溶于水的聚合物，而且不被消化酶水解，不被人体吸收，仅是通过人体，而后被排泄。
药动学
本品与其他常用的降低胆固醇的药物不同，该药物不被吸收进入血液而散布全身，不会导致全身性副作用，药动学性质简单。
适应证
本品可以单独使用以降低低密度脂蛋白胆固醇水平，用作原发性高胆固醇血症病人饮食和运动的辅佐治疗；另外，该药物还是惟一经FDA批准的可与他汀类药物联合使用的降脂药。对以胆固醇升高为主的高脂血症，当饮食和锻炼不能很好达到效果时，本品单独使用或与他汀类合用可有效的降低血浆胆固醇浓度。
禁忌证
本品禁用于肠功能紊乱者，以及对药物中任一组分过敏者。
注意事项
当患者总胆固醇水平高于7.8mmol/L时，一般不使用本品，如需使用应谨慎。非临床安全性研究显示，大鼠给予本品人体用药剂量的30倍可因维生素K缺乏而引起出血。
不良反应
本品可引起头痛、疼痛和无力等中枢神经系统不良反应；耳鼻喉方面常见有咽炎、鼻炎、鼻窦炎等不良反应；胃肠方面可引起腹痛、便秘、腹泻、消化不良、胃肠胀气和恶心等不良反应；骨骼肌肉系统的不良反应有肌痛和背痛；呼吸系统有咳嗽；皮肤方面可引起损伤、感染及感染综合征等。 本品因不被吸收而无全身副作用，本品与其他药之间的交叉反应也很小。
用法用量
口服，推荐起始剂量为3片/次，2次/d，或6片/次，1次/d。根据需要剂量可调整为7片/d。和HMG-COA还原酶抑制剂合用时，以4～6片/次较为安全和合适。
药物相应作用
本品与其他药物同服时，未见本品对地高辛、洛伐他汀、美托洛尔、奎尼丁、丙戊酸和华法林生物利用度有明显影响。本品可使丙戊酸缓释剂(Calan SR)的Cmax和AUC分别降低31%和11%。尽管临床丙戊酸的生物利用度具有较大的可变性，但原因目前尚不清楚。
本品与阿托伐他汀、洛伐他汀或辛伐他汀同服不会影响他汀类药物的降脂作用。但尚未在其他药物中进行有关研究。当与可能干扰药物血浓度的其他药物同服时，药物的安全性和有效性可能受到影响，用药时应考虑进行药物浓度监测。
本品在与其他药物联用时虽不易产生副作用，但患者还是应该在服用本品前告诉医生是否正在服用的其他药物。 如果患者不能耐受他汀类药物，单独使用本品也可以达到很好的效果。本品由于不被吸收，使用时的安全性将比目前被广泛使用的其他降血脂药物如他汀类药物显著增高。
临床研究
临床试验表明，在降低LDL胆固醇方面本品是有效的和安全的。特别是当本品与他汀类药物联合使用时，能够很好的达到降低胆固醇的作用。
临床研究显示，对于原发性高胆固醇血症患者，本品无论单用或与他汀类药物(如洛伐他汀、辛伐他汀等)合用均可降低其总胆固醇、LDL-ch和载脂蛋白B(Apo B)水平，同时升高HDL胆固醇水平，且这种效果是单用其中任一种药物所达不到的。约有1400例患者参与为期分别为4～50周的8项研究，其中除1项长程研究外，其余均为多中心随机双盲安慰剂对照研究。研究显示，本品用药后2周可达最大疗效，且这1疗效在整个长程研究中始终保持。
LDL-ch水平在3.38～5.72mmol/L(平均4.12mmol/L)的患者中进行的研究显示，在早餐和晚餐分别给予本品3.8g和4.5g，用药24周可使LDL-ch平均降低15%和18%；总胆固醇平均分别降低7%和10%；而Apo B两组均平均降低12%。本品2种剂量均使HDL胆固醇升高3%，两组甘油三酯轻度升高，与安慰剂组相比未见有统计学意义的明显差异。 98例LDL-ch在3.77～6.50mmol/L(平均4.39mmol/L)的患者中进行的研究显示，本品3.8g分别与早餐、晚餐同服或与早餐或晚餐分开服用，治疗6周后3种给药方案分别使平均LDL-ch降低18%，15%和18%，三组间无明显差异。本品与他汀类药物如阿托伐他汀(atorvastin)、洛伐他汀(lovastatin)或辛伐他汀(simvastatin)联合使用的3项临床研究显示，联合用药可使LDL-ch进一步降低。

Cholestagel 625mg film-coated tablets
1. Name of the medicinal product
Cholestagel 625 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 625 mg colesevelam (as hydrochloride).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.
4. Clinical particulars
4.1 Therapeutic indications
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.
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.
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).
4.2 Posology and method of administration
Posology
Combination therapy
The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day. The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal. Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be co-administered or dosed apart.
Monotherapy
The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal. The maximum recommended dose is 7 tablets per day.
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.
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).
Elderly population
There is no need for dose adjustment when Cholestagel is administered to elderly patients.
Paediatric population
The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Method of administration
Cholestagel tablets should be taken orally with a meal and liquid.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Bowel or biliary obstruction
4.4 Special warnings and precautions for use
Secondary causes of hypercholesterolaemia
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.
Interaction with ciclosporin
For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin: Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5). Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal. Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly. It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations. Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.
Effects on triglyceride levels
Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/L due to the triglyceride increasing effect with Cholestagel. 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.
The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established. Consequently, caution should be exercised when Cholestagel is used in patients with these disorders.
Constipation
Cholestagel can induce or worsen present constipation. The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Anticoagulants
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).
Oral contraceptives
Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously. 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).
4.5 Interaction with other medicinal products and other forms of interaction
In general
Cholestagel may affect the bioavailability of other medicinal products. Therefore when a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimize the risk of reduced absorption of the concomitant medication. For concomitant medications which require administration via divided doses, it should be noted that the required dose of Cholestagel can be taken once a day.
When administering medicinal products for which alterations in blood levels could have a clinically significant effect on safety or efficacy, physicians should consider monitoring serum levels or effects.
Interaction studies have only been performed in adults.
In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin. Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively. Since there is a high degree of variability in the bioavailability of verapamil, the clinical significance of this finding is unclear.
Co-administration of colesevelam and olmesartan decreases the exposure of olmesartan. Olmesartan should be administered at least 4 hours prior to colesevelam.
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Anticoagulant therapy
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. Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Levothyroxine
In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour. No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
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. This interaction was also observed when Cholestagel was administered one hour after the oral contraceptive pill. However no interaction was observed when Cholestagel was administered four hours after the oral contraceptive pill.
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. Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4). 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. Furthermore, Cholestagel should always be administered at the same times consistently since the timing of intake of Cholestagel and ciclosporin could theoretically influence the degree of reduced bioavailability of ciclosporin.
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. Cholestagel had no effect on the bioavailability of lovastatin in an interaction study.
Antidiabetic agents
Co-administration of colesevelam and metformin extended-release (ER) tablets increases the exposure of metformin. Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs.
Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract. No interaction was observed when glimepiride was taken at least 4 hours before colesevelam. Therefore glimepiride should be administered at least 4 hours prior to colesevelam.
Co-administration of colesevelam and glipizide decreases the exposure of glipizide. Glipizide should be administered at least 4 hours prior to colesevelam.
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. No interaction was observed when Cholestagel was administered four hours after glyburide.
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. No interaction was observed when Cholestagel was administered one hour after repaglinide.
No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Ursodeoxycholic acid
Cholestagel predominantly binds hydrophobic bile acids. In a clinical study Cholestagel did not affect the faecal excretion of endogenous (hydrophilic) ursodeoxycholic acid. However, formal interaction studies with ursodeoxycholic acid have not been performed. As noted in general, when a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimise the risk of reduced absorption of the concomitant medication. Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered.
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. However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption. In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
4.6 Fertility, pregnancy and lactation
Pregnancy
No clinical data are available on the use of Cholestagel in pregnant women. 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). Caution should be exercised when prescribing to pregnant women.
Breast-feeding
The safety of Cholestagel has not been established in breast-feeding women. Caution should be exercised when prescribing to breast-feeding women.
Fertility
There are no data on the effect of Cholestagel on fertility in humans. A study conducted in rats did not result in any differences in reproductive parameters between the groups that might imply reproductive effects attributable to colesevelam.
4.7 Effects on ability to drive and use machines
Cholestagel has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class.
Tabulated list of adverse reactions
In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Nervous system disorders

Common: Headache

Gastrointestinal disorders

Very common: Flatulence*, constipation*

Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension

Uncommon: Dysphagia

Very rare: Pancreatitis

Not known: Intestinal obstruction*,**

Musculoskeletal and connective tissue disorders

Uncommon: Myalgia

Investigations

Common: Serum triglycerides increased

Uncommon :Serum transaminases increased

see section below for further information
dverse reactions from post-marketing experience
Description of selected adverse events
The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies. Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.
The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.
Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Since Cholestagel is not absorbed, the risk of systemic toxicity is low. Gastrointestinal symptoms could occur. Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Mechanism of action
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. These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans. Cholesterol is the sole precursor of bile acids. During normal digestion, bile acids are secreted into the intestine. A major portion of bile acids is then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.
Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. 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-α-hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids. 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. A concomitant increase in very low density lipoprotein synthesis can occur. These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
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. In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%. Apo B decreased by 12%. In comparison, in patients given placebo, LDL-C, Total-C, HDL-C and Apo-B were unchanged, while triglycerides increased 5%. 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. However, in one study triglycerides tended to increase more when Cholestagel was given as a single dose with breakfast.
In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone. The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients). Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted. The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
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.
The effect of 3.8 g Cholestagel plus 10 mg ezetimibe versus 10 mg ezetimibe alone on LDL-C levels was assessed in a multicentre, randomised, double-blind, placebo-controlled, parallel-group study in 86 patients with primary hypercholesterolaemia over a 6-week treatment period. 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.
The addition of Cholestagel 3.8 g daily to maximally-tolerated statin and ezetimibe therapy was assessed in a multi-centre, randomised, double-blind, placebo-controlled study in 86 patients with familial hypercholesterolaemia. A total of 85% of the patients were on either atorvastatin (50% of whom received 80 mg dose) or rosuvastatin (72% of whom received 40 mg dose). 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. 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. HDL-C and hsCRP levels were also not significantly different compared to placebo at 12 weeks.
Paediatric population
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%). For all patients, Cholestagel resulted in a statistically significant LDL-C reduction of 11% at 3.8 g/day and 4% at 1.9 g/day, versus a 3% increase in the placebo group. For statin-naïve patients on monotherapy, Cholestagel resulted in a statistically significant LDL-C reduction of 12% at 3.8 g/day and 7% at 1.9 g/day, versus a 1% reduction in the placebo group (see section 4.2). There were no significant effects on growth, sexual maturation, fat-soluble vitamin levels or clotting factors, and the adverse reaction profile for Cholestagel was comparable to that seen with placebo.
Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
So far, no studies have been conducted that directly demonstrate whether treatment with Cholestagel as monotherapy or combination therapy has any effect on cardiovascular morbidity or mortality.
5.2 Pharmacokinetic properties
Cholestagel is not absorbed from the gastrointestinal tract.
5.3 Preclinical safety data
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.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core:
Cellulose (E460), microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Water, purified
Film-coating:
Hypromellose (E464)
Diacetylated monoglycerides
Printing ink:
Iron oxide black (E172)
Hypromellose (E464)
Propylene glycol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Keep the bottle tightly closed in order to protect from moisture.
6.5 Nature and contents of container
High density polyethylene bottles with a polypropylene cap.
Package sizes are:
24 tablets (1 X 24)
100 tablets (2 X 50)
180 tablets (1 X 180) 
High density polyethylene bottles with a polypropylene cap without outer carton.
Package sizes are:  180 tablets (1 X 180)
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands.
8. Marketing authorisation number(s)
EU/1/03/268/001-004
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 10 March 2004
Date of latest renewal: 12 March 2009
10. Date of revision of the text
18 December 2014
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
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产地国家：德国 
原产地英文商品名:
Cholestagel filmcoated 625mg/tablets 180tablets/bottle 
原产地英文药品名:
Colesevelam
中文参考商品译名:
Cholestagel薄膜衣片 625毫克/片 180片/瓶
中文参考药品译名:
考来维仑
生产厂家中文参考译名:
SANOFI
生产厂家英文名:
SANOFI
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产地国家：荷兰
原产地英文商品名:
Cholestagel filmcoated 625mg/tablets 180tablets/bottle 
原产地英文药品名:
Colesevelam
中文参考商品译名:
Cholestagel薄膜衣片 625毫克/片 180片（其中另有24、100片包装，采购以咨询为准）/瓶
中文参考药品译名:
考来维仑
生产厂家中文参考译名:
Genzyme Europe B.V
生产厂家英文名:
Genzyme Europe B.V