简介:
部分中文氢氧化钠阿仑膦酸钠处方资料(仅供参考)
英文名:Alendronate Sodium Hydrate
商品名:Bonalon
中文名:氢氧化钠阿仑膦酸钠输液
生产商:帝人制药
ボナロン点滴静注バッグ900μg
药物类别名称
骨质疏松症治疗剂
批准日期:2012年5月
商品名
Bonalon Bag for I.V. Infusion 900μg
一般的名称
アレンドロン酸ナトリウム水和物(Alendronate Sodium Hydrate)
化学名
Monosodium trihydrogen 4-amino-1-hydroxybutane-1,1-diyldiphosphonate trihydrate
分子式
C4H12NNaO7P2・3H2O
分子量
325.12
性状
它是一种白色结晶粉末。它在水中的可溶性略低,几乎不溶于乙醇 (99.5)。它溶解在0.1mol/L柠酸三钠的测试溶液中。
化学構造式
熔点
约 252°(分解,但干燥后)
处理注意事项
为了保持产品质量,在使用前不要打开包装本产品的外袋。 此外,开封后立即使用。
请勿使用包装中由水滴着色或云彩或有颜色或云彩的任何物品。
容器的液垢应作为近似指南。
药用药理学
作用机制
Alendronic酸对骨质磷灰石有很强的亲和力,有选择性地分布在大鼠体内存在成骨细胞的骨表面。 Alendronic酸通过抑制骨吸收后将其活性抑制来减少骨吸收。
对骨量减少的影响
(参见表 5)
对骨钙化的影响
钠过敏酸水合物,施用一年以上的骨体积减少模型(大鼠:1年,小熊:2年)时执行,结果表明骨钙化障碍在一个剂量,以抑制骨体积减少尚未获得。 在大鼠的生长过程(Schenk评估系统),抑制骨吸收的剂量约为损害骨钙化剂量的1/6000,显示了广泛的安全范围。
适应症
骨质疏松症
用法与用量
通常,成人每4周服用一次超过30分钟900μg的过敏酸。
包装
100mLx1袋
制造和销售
帝人药业有限公司
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件:http://www.info.pmda.go.jp/go/pack/3999419G1024_1_10/
Teijin Pharma's Bonalon Bag for I.V. Infusion 900 µg Approved as Japan's First I.V. Drug for Osteoporosis
January 18, 2012 --- Teijin Pharma Limitedthe core company of the Teijin Group’s medical and pharmaceutical business, announced today that Japan’s Ministry of Health, Labour and Welfare on January 18 approved Bonalon Bag for I.V. Infusion 900 µg (Alendronate sodium hydrate) as Japan’s first intravenous drip-form drug for osteoporosis. Teijin Pharma plans to launch the drug, which is administered just once every four weeks.
The approval will enable Teijin Pharma, which holds the largest share of osteoporosis treatments in Japan, to strengthen its commitment to improving the quality of life of patients.
Bonalon Bag for I.V. Infusion 900 µg, Japan’s first intravenous drip formulation for osteoporosis, is based on the oral bisphosphonate drug Bonalon, but does not impose the administration restrictions of oral drugs. In addition, while Bonalon is administered orally once a day or once a week, Bonalon Bag for I.V. Infusion 900 µg can be administered once every four weeks, when the patient visits their clinics, making it easier for them to continue taking the medication. Also, whereas Bonalon as an oral drug is accompanied by the risk of disorders in digestive organs due to the drug coming into contact with these organs, the administration of the drug as a drip infusion avoids this risk.
Japan has an estimated 11 million osteoporosis patients, mainly elderly women. In addition to increasing the risk of proximal femoral fractures, a direct cause of elderly people becoming bedridden or increased risk of death, osteoporosis also can have various harmful effects on ambulatory ability and visceral and respiratory functions. Moreover, evidence is increasingly linking the disease to lifestyle diseases such as hyperlipidemia and diabetes. In view of the aging of Japanese society, interest in osteoporosis treatment is increasing.
Bonalon, a bisphosphonate drug with an outstanding capacity to inhibit bone resorption, has been confirmed to increase the bone density of osteoporosis patients and reduce the occurrence of proximal femoral fractures. In the “Guidelines for the Prevention and Treatment of Osteoporosis - 2011 Version,” which was presented at the Annual Meeting of Japan Osteoporosis Society in November of last year, Bonalon was highly eva luated for its potential effects to reduce the risk of fractures such as proximal femoral fractures. In addition, efficacy and safety were proven in a long-term administration study overseas, in which patients used the drug continuously for over a decade.
In the case of most orally administered bisphosphonate drugs, however, patients are advised that after rising and taking the drug with a glass of water, they should not lie down for 30 minutes after administration, nor drink or eat during that time. The inconvenience of these restrictions has led to some patients discontinuing their use of the medication. |