【性 狀】本品為膠囊劑，內(nèi)容物為白色或類白色顆粒。
【Description】This product is formulated as capsule, the contents is white or off-white granule.
【適 應(yīng) 癥】可用于預(yù)防同種腎移植病人的排斥反應(yīng)，及治療難治性排斥反應(yīng)，嗎替麥考酚酯膠囊可與環(huán)孢素和腎上腺皮質(zhì)激素同時(shí)應(yīng)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.
【規(guī) 格】0.25g（按C23H31NO7計(jì)）
【Specification】0.25g (Calculated on C23H31NO7)
【用法用量】
預(yù)防排異劑量
應(yīng)于移植72小時(shí)內(nèi)開始口服。腎移植病人服用推薦劑量為1克一天兩次（一天2克）。日服嗎替麥考酚酯膠囊2克/天比口服3克/天安全性更好。
治療難治性排斥的劑量
臨床試驗(yàn)中，治療難治性排斥的首次和維持劑量推薦為1.5克一天兩次（3克/天）。
特殊劑量:
如果發(fā)生中性粒細(xì)胞減少(中性粒細(xì)胞計(jì)數(shù)絕對(duì)值<1.3×103/微升），應(yīng)停止或減量。嚴(yán)重腎功能損害：對(duì)有嚴(yán)重慢性腎功能損害的病人（腎小球?yàn)V過率<25毫升/分/1.73平方米），應(yīng)避免超過1克一天兩次的劑量（移植后即刻使用除外）。對(duì)這些病人應(yīng)仔細(xì)觀察。對(duì)腎移植后腎功能延期恢復(fù)的病人不需要做劑量調(diào)整或遵醫(yī)囑。【 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 裝】0.25g：鋁塑包裝：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個(gè)月。
【Validity】24 months
【執(zhí)行標(biāo)準(zhǔn)】國(guó)家食品藥品監(jiān)督管理局標(biāo)準(zhǔn) YBH11122008
【Executive standard】The state food and drug administration standards YBH11122008
【批準(zhǔn)文號(hào)】國(guó)藥準(zhǔn)字H20080642
【Approval Number】SFDA Approval No. H20080642
