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PHARMACODYNAMICS 药效学 Specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. 长效的胃肠脂肪酶抑制剂。它通过与胃和胰脂肪酶的活性丝氨酸位点形成共价键,在胃和小肠的管腔中发挥其治疗活性。因此,灭活的酶不能将甘油三酯形式的膳食脂肪水解成可吸收的游离脂肪酸和甘油单酯。 Elimination 排除 Fecal excretion of the unabsorbed was the major route of elimination. Approximately 97 % of the administered dose was excreted in surface 未吸收药物的粪便排泄是主要的消除途径。大约 97% 的给药剂量在排泄 The cumulative renal excretion of total orlistat-related materials was < 2% of the given dose. The time to reach complete excretion (faecal plus urinary) was 3 to 5 days. The disposition between normal weight and obese volunteers, all subject to biliary excretion. 排泄(粪便加尿)的时间为 3 至 5 天。他的代谢分布在正常体重和肥胖志愿者之间似乎相似, 均经胆汁排泄。 INDICATIONS 适应 Effective in weight loss, weight maintenance and prevention of weight regains. Treatment with Aslene results in an improvement of risk factors and comorbidities associated with obesity, including hypercholesterolemia, noninsulin dependent diabetes mellitus (NIDDM), Impaired glucose tolerance, hyperinsulinemia, hypertension and in a reduction of visceral fat. 可有效减轻体重、维持体重和预防体重反弹。 它可以治疗改善与肥胖相关的风险因素和合并症,包括高胆固醇血症、非胰岛素依赖型糖尿病 (NIDDM)、葡萄糖耐量受损、高胰岛素血症、高血压和内脏脂肪减少。 DOSAGE AND ADMINISTRATION 剂量和管理 The recommended an120mg capsule with each main meal (during or up to one hour after the meal). If a meal is missed or contains no fat, the dose of Aslene may be omitted. 推荐剂量是每顿主餐服用一粒 120 mg胶囊(饭后或饭后一小时)。如果错过一餐或不含脂肪,则可以省略它的剂量。 The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate and protein should be distributed over three main meals. 患者应采用营养均衡、低热量的饮食,其中大约 30% 的热量来自脂肪。脂肪、碳水化合物和蛋白质的每日摄入量应分布在三餐中。 CONTRAINDICATIONS 禁忌 Contraindicated in patients with chronic malabsorption syndrome, cholestasis 禁用于患有慢性吸收不良综合征、胆汁淤积的患者 Use during pregnancy 怀孕期间使用 Not recommended for use during pregnancy in the absence of clinical data. 在没有临床数据的情况下,不建议在怀孕期间使用 Use during lactation 哺乳期使用 Should not be taken during breast-feeding. 哺乳期间不应服用。 SHELF-LIFE 保质期 The expiry date is indicated on the packaging. STORAGE CONDITION 保存方法 Store below 25℃ and away from excessive heat, light and moisture not keep in the bathroom. 存放于25℃以下,远离过热、光照和潮湿,不要放在浴室里。 KEEP OUT OF REACH OF CHILDREN 请将本品放在儿童不能接触的地方。
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