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        【性    狀】本品為膠囊劑,內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 癥】可用于預防同種腎移植病人的排斥反應,及治療難治性排斥反應,嗎替麥考酚酯膠囊可與環孢素和腎上腺皮質激素同時應用。

        【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    格】0.25g(按C23H31NO7計)

        【Specification】0.25g  (Calculated on C23H31NO7)


        【用法用量】

        預防排異劑量

        應于移植72小時內開始口服。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:

        如果發生中性粒細胞減少(中性粒細胞計數絕對值<1.3×103/微升),應停止或減量。嚴重腎功能損害:對有嚴重慢性腎功能損害的病人(腎小球濾過率<25毫升/分/1.73平方米),應避免超過1克一天兩次的劑量(移植后即刻使用除外)。對這些病人應仔細觀察。對腎移植后腎功能延期恢復的病人不需要做劑量調整或遵醫囑?!?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個月。

        【Validity】24 months


        【執行標準】國家食品藥品監督管理局標準 YBH11122008

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


        【批準文號】國藥準字H20080642

        【Approval Number】SFDA Approval No. H20080642



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