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Maxacalcitol I.V. Injection 5μg ampul(马沙骨化醇注射剂「テバ」)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 5微克/1毫升/安醅 10安醅/盒 
包装规格 5微克/1毫升/安醅 10安醅/盒 
计价单位: 盒 
生产厂家中文参考译名:
武田药品
生产厂家英文名:
Takeda Pharmaceuticals
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3112401A1034_1_02/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Maxacalcitol I.V. Injection(マキサカルシトール静注透析用)5μg/1ml/ampul 10ampuls/box
原产地英文药品名:
Maxacalcito
中文参考商品译名:
Maxacalcitol(マキサカルシトール静注透析用)5微克/1毫升/安醅 10安醅/盒
中文参考药品译名:
马沙骨化醇
曾用名:
简介:

 

部份中文马沙骨化醇处方资料(仅供参考)
商品名:Maxacalcitol I.V. Injection for Dialysis
英文名:Maxacalcitol
中文名:马沙骨化醇
生产商:武田药品
マキサカルシトール静注透析用2.5μg「テバ」/マキサカルシトール静注透析用5μg「テバ」/マキサカルシトール静注透析用10μg「テバ」
藥用類別名稱
繼發性甲狀旁腺甲狀腺功能亢進治療劑
批准日期:2015年12月
商標名
Maxacalcitol I.V. Injection for Dialysis 2.5μg "TEVA
Maxacalcitol I.V. Injection for Dialysis 5μg "TEVA
一般名
マキサカルシトール(Maxacalcitol)
化学名
(+)-(5Z,7E)-(1S,3R,20S)-20-(3-Hydroxy-3-methylbutyloxy)-9,10-secopregna-5,7,10(19)-triene-1,3-diol
分子式
C26H42O4
分子量
418.61
構造式
性状
・它是一種白色結晶性粉末。
・它很溶于甲醇, 易溶于乙醇 (99.5), 微溶于乙腈, 不易溶于水。
操作注意事項
穩定性試驗
(1)mazoxaltol 靜脈透析2.5微克 "nipro" 長期儲存試驗(10°c, 3年)結果、外觀和含量等均在標準範圍內, 對 mazoxaltol 靜脈透析為2.5μg 在正常的市場分佈下, "尼普" 已經被確認穩定了三年。
(2) makoxalacol 靜脈透析為5微克 "nipro" 長期儲存試驗 (10°c, 3年) 結果、外觀和含量等均在標準範圍內, 5微克用於 makoxalacol 靜脈透析 " 在正常的市場分佈下, "尼普" 已經被確認穩定了三年。
(3) mazoxaltol 靜脈注射透析10μg "nipro" 長期儲存試驗 (10°c, 3年) 結果、外觀和含量等均在標準範圍內, 10[mu]g為makoxaltol 靜脈透析 在正常的市場分佈下, "尼普" 已經被確認穩定了三年。
藥用藥理學
馬沙利醇是強烈抑制pth基因表達, 對小腸和骨也沒有什麼活性。
适应症
維持性透析中的繼發性甲狀旁腺甲狀腺功能亢進
用法与用量
通常情況下, 成人, 作為一個 makoxalitol 就在透析結束前, 每週三次每次 2.5 ~ 10μg, 注射到透析回路靜脈側 (靜脈注射)。 在不能獲得改善血清甲狀旁腺激素 (pth) 效果的情況下, 在注意高鈣血症表達的同時, 謹慎地逐步提高上限為一次 20 [mu] g。
包装
靜脈注射透析
●2.5μg(1管 1mL2.5μg)10管
●5μg(1管1mL5μg)10管
●10μg(1管1mL10μg)10管
制造厂商
武田药品
注:以上中文不够完整,使用者以原处方资料为准。
完整说明附件:http://www.info.pmda.go.jp/go/pack/3112401A1034_1_02/ 
Maxacalcitol I.V. Injection for Dialysis(Maxacalcito)
Product name:
Maxacalcitol I.V. Injection for Dialysis 2.5 μg "TEVA"
Maxacalcitol I.V. Injection for Dialysis 5 μg "TEVA"
Maxacalcitol I.V. Injection for Dialysis 10 μg "TEVA"
Development and listed companies (Japan) Chinese and foreign pharmaceutical companies
September 10, 2000 listed in Japan for the first time.
Characteristics of Masha calciferol
Maxacalcitol (maxacalcitol) is a new type of vitamin D agonist, for the treatment of secondary hyperparathyroidism caused by vitamin D metabolic abnormalities.
This product on normal bovine parathyroid cells and chronic renal failure caused by secondary hyperparathyroidism in patients with parathyroid cells showed inhibition of parathyroid hormone (PTH) secretion of the effect of its effect and calcitriol To a considerable extent. In renal failure model animals (5/6 kidney removal of rats, ligation of the renal artery of the dog), the product does not cause elevated serum calcium levels in the case, can still show inhibition of PTH secretion. The rats were treated with Chai Tian nephritis to study the effect of this product on the secondary hyperparathyroidism caused by bone lesions, that this product can reduce the metabolic hyperthyroidism caused by bone changes. In addition to the dog kidney failure model of bone lesions inhibit the role of fibrous bone formation. In normal rats and renal failure rats, the goods inhibit the expression of parathyroid hormone (prepro-PTH) mRNA. In addition this product on osteoblast-like cells, can promote the expression of osteocalcin gene.
The pharmacokinetic parameters of 6 healthy adult men after intravenous administration of 3.3 μg and 6.6 μg of this product were: area under the curve (AUC) of 354 ± 135 pg / h and 795 ± 192 pg ; The half-life was 108.1 ± 45.9 minutes and 138.7 ± 39.9 minutes; the clearance rate was 237 ± 70 ml / mg and 174 ± 50 ml / mg per hour; the distribution volumes were 259 ± 48 ml / kg and 362 ± 32 ml /kilogram. In the maintenance of dialysis, accompanied by secondary hyperparathyroidism in 14 patients, in 26 weeks during each dialysis to give the goods 10 ~ 17.5 micrograms, the results compared with the first, the final single dose Of the AUC has a downward tendency, half-life also has shortened the tendency. But compared with healthy people, elimination is not slow.
In patients with secondary hyperparathyroidism due to chronic renal failure, a double-blind, double-blind, placebo-controlled study (placebo, 5 micrograms, 10 micrograms, and 15 micrograms per week for patients with dialysis) Times, the intravenous side of the dialysis circuit), the complete PTH and PTH improvement as the clinical eva luation, that its usefulness and dose were significantly correlated. In addition, although the effect of inhibition of intact PTH, 10 micrograms of dose than 5 micrograms, and 15 micrograms of the same, but the role of serum calcium level of 10 micrograms than 15 micrograms, and 5 micrograms.
In patients with chronic renal failure dialysis patients for phase Ⅲ clinical double-blind controlled trial (placebo, the product 1 5 micrograms and 10 micrograms, 3 times a week, dialysis circuit intravenous side), PTH improvement , Comprehensive improvement and usefulness of the product group than the placebo group was excellent, apparently to improve the secondary hyperparathyroidism is effective.
Long-term administration of serum calcium levels can be observed increased, indicating the use of this product has a sustained inhibition of PTH effect.
Adverse reactions: The main adverse reactions of this product hypercalcemia, followed by pruritus, creatine kinase (CK) levels, anxious and myoglobin, lactose dehydrogenase, serum inorganic phosphorus levels and white blood cell differentiation Lymphocyte abnormalities, eosinophil abnormalities, insomnia and so on. 

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