【性    状】本品为胶囊剂，内容物为白色或类白色颗粒。

【Description】This product is formulated as capsule, the contents is white or off-white granule.

【适 应 症】可用于预防同种肾移植病人的排斥反应，及治疗难治性排斥反应，吗替麦考酚酯胶囊可与环孢素和肾上腺皮质激素同时应用。

【Indications】

It can be used to prevent rejection reaction of the same kind of kidney transplant patients, and treat refractory rejection reaction. It can be used together with cyclosporine and adrenocortical hormone.

【规    格】0.25g（按C23H31NO7计）

【Specification】0.25g  (Calculated on C23H31NO7)

【用法用量】

预防排异剂量

应于移植72小时内开始口服。肾移植病人服用推荐剂量为1克一天两次（一天2克）。日服吗替麦考酚酯胶囊2克/天比口服3克/天安全性更好。 

治疗难治性排斥的剂量

临床试验中，治疗难治性排斥的首次和维持剂量推荐为1.5克一天两次（3克/天）。

特殊剂量:

如果发生中性粒细胞减少(中性粒细胞计数绝对值<1.3×103/微升），应停止或减量。严重肾功能损害：对有严重慢性肾功能损害的病人（肾小球滤过率<25毫升/分/1.73平方米），应避免超过1克一天两次的剂量（移植后即刻使用除外）。对这些病人应仔细观察。对肾移植后肾功能延期恢复的病人不需要做剂量调整或遵医嘱。【 Dosage 】

Dosage for preventing rejection reaction:

It should be taken within 72 hours after transplantation. The recommended dose of the renal transplant patients is twice daily, 1g every time (2g daily). The security of 2g daily is better than that of 3g daily.

Dosage for the treatment of refractory rejection:

During the clinical trials, the recommended first and maintenance dosage for treatment of refractory rejection is 1.5 g every time, twice daily (3 g/day)

Special dosage: 

If the count of neutrophilic granulocyte decreases (absolute value < 1.3×103 per microliter), it should be stopped or reduce the dosage. The dosage for the patient with severe renal impairment (GFR < 25 ml/min / 1.73 m2) should be less than 1 gram, twice a day (except immediate usage after transplantation). These patients should be carefully observed. The dosage for the patient on delayed recovery of renal function after kidney transplantation don't need to be adjusted or follow the doctor’s advice.

【包   装】0.25g：铝塑包装：10粒/板×4板/盒，10粒/板×10板/盒。

【Packing】0.25g，Aluminum Plastic Packaging: 10 capsules/board×4 boards/box; 10 capsules/board×10 boards/box;

【有 效 期】24个月。

【Validity】24 months

【执行标准】国家食品药品监督管理局标准 YBH11122008

【Executive standard】The state food and drug administration standards YBH11122008

【批准文号】国药准字H20080642

【Approval Number】SFDA Approval No. H20080642