产地国家：日本　 处 方 药：是 所属类别：3微克/胶囊 100胶囊/盒 包装规格：3微克/胶囊 100胶囊/盒 计价单位：盒 生产厂家中文参考译名：中外制药 生产厂家英文名：Chugai Pharmaceutical Co 原产地英文商品名：ALFAROL(アルファロールカプセル)3μg/Capsule 100Capsule/box 原产地英文药品名：Alfacalcidol 中文参考商品译名：ALFAROL(アルファロールカプセル)3微克/胶囊 100胶囊/盒 中文参考药品译名：阿法骨化醇

简介

——ALFAROL(Alfacalcidol：阿法骨化醇)是一种新型治疗肾功能衰竭、骨软化等顽症的新药 治疗类别名称：是骨代谢改善1α-OH-D3配方 商標名：ALFAROL 一般名：Alfacalcidol(JAN) 化学名：(5Z, 7E)-9, 10-Secocholesta-5, 7, 10(19)-triene-1α, 3β-diol 慣用名：1α-hydroxycholecalciferol，1α-hydroxyvitamin D3 分子式：C27H44O2 分子量：400.64 性　状 它是一种白色晶体或结晶粉末。 甲醇，乙醇(99.5)，易溶于氯仿，二氯甲烷，易于在丙酮或乙醚微溶，并在水或己烷几乎不溶。 通过空气或在光照的变化。 熔点(部分分解) 135-138℃(天站通用试验方法) 137-142℃(天站维生素D 2的测量方法) 适应病症 慢性肾功能衰竭，甲状旁腺功能减退，维生素-D抗性佝偻病，骨软化，骨质疏松 用法用量 根据患者的血清钙浓度的适当管理，调整剂量。 慢性肾功能衰竭，在骨质疏松症 每天口服给药，0.5-1.0μg。然而，增加或减少取决于患者的年龄和症状。 甲状旁腺功能减退，与疾病其它维生素D代谢异常 每天口服给药，1.0-4.0μg。剂量可根据病情，患者的年龄，状况，由疾病类型进行调整 (小儿用量) 每天一次，每次0.05-0.1微克/千克至0.01-0.03μg/kg，在其它疾病的情况下，作为阿法骨化醇，每天一次在骨质疏松症的儿童的情况下和口服给药。 然而，剂量可根据病情，症状进行调整。 药效药理 1. 起效(25位氢氧阿法骨化醇) 由鼠肝灌注，它被迅速代谢1α，所述25-(OH)2D3。在肝脏中25位羟基化也已在四氯化碳或半乳糖胺给药(大鼠)的肝功能衰竭的时间保持。 2.作用和效果 (1) 对维生素D缺乏或低磷，高钙饮食饲养的大鼠，显示抗佝偻病作用，促进骨矿化前面形成的作用。 (2) 阿法骨化醇活性代谢物1α的，是25-(OH)2D3与骨吸收和骨重建作用(增殖和软骨细胞分化成骨细胞)(体外)。 (3) 通过骨形态阿尔法卷管理，增加骨质表面比与成骨细胞，直接作用于成骨细胞，促进骨形成已建议(人类骨质疏松症)。 (4) 通过每日施用，血清1α，25-(OH)，以提高在小肠中，已经与2D值(人骨质疏松症)的上升沿下降的钙吸收速率。 (5) 对于低钙血病，钙吸收促进从小肠(人慢性肾功能衰竭，甲状旁腺功能减退症)由骨矿物质洗脱作用(肾或甲状旁腺大鼠)动作，以增加血清钙 血清钙值管理停药后呈现快速下降，半衰期由于已报告3.4天(人)血清钙的变化。 (6) 骨吸收窝面肾性骨营养不良的，以提高增稠的类骨质层(人慢性肾功能衰竭，柴田肾炎大鼠。 此外，为减少甲状旁腺体重和血液甲状旁腺激素是肥大，抑制的继发性甲状旁腺功能亢进。 (7) 口服给药阿法骨化醇的工作是，1α，它是等效25-(OH)2D3或多于已经建议(人，柴田肾炎大鼠)。 包装规格 0.25微克：100(PTP)500(PTP，瓶)700(PTP)胶囊 0.5微克：100(PTP)500(PTP，瓶)700(PTP)胶囊 1微克：100(PTP)500(PTP，瓶)700(PTP)胶囊 制造厂商 中外制药有限公司

英文版说明书

ALFAROL Capsule(Alfacalcidol) ALFAROL Capsule 3μg(アルファロールカプセル3μg) Brand name : ALFAROL Capsule 3μg Active ingredient: Alfacalcidol Dosage form: opaque white capsule (φ: 5.6mm) Print on wrapping: アルファロール3 Effects of this medicine This hepatically-metabolized medicine turns into activated vitamin D3 and promotes digestive tract absorption of calcium. It is usually used to treat osteoporosis as well as to improve bone disease and other symptoms caused by lack of vitamin D. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <> •General dosage regimen: Your dosage of this medicine is adjusted under a fully controlled condition of serum calcium level. To treat chronic renal failure: For adults, take 0.5-1.0μg of the active ingredient once a day. It should be adjusted according to your disease, age and symptoms. To treat hypoparathyroidism and other disease caused by vitamin D metabolism abnormality: For adults, take 1.0-4.0μg of the active ingredient once a day. It should be adjusted according to your disease, age, symptoms and pattern of disease. For children: In the case of osteoporosis, take 0.01-0.03 μg/kg of the active ingredient once a day. In the case of other diseases, take 0.05-0.1μg/kg of the active ingredient once a day. It should be adjusted according to your disease and symptoms. 1 capsule contains 3μg of the active ingredient. Strictly follow the instructions of your doctor in any case. •Skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose. •If you took too much of this medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking this medicine without the instructions of your doctor. Precautions while taking this medicine •If you take a large amount of calcium or vitamin D contained in OTC medicine or food while taking this medicine, you may have a higher risk of side effects. Check with your doctor about it beforehand. Possible adverse reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: pruritus, loss of appetite, nausea, diarrhea. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •decreased urinary volume, largely increased urinary volume, urinary retention, difficult urination, swollen body/legs/eyes, lassitude, easy fatigability, redden eyes, symptoms of hypercalcemia such as itch and irritation [acute renal failure] •yellowness in the skin and/or the white of the eye, lassitude [hepatic dysfunction, jaundice] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep out of the reach of children. Store in a covered container, at room temperature (1-30℃). Keep away from light and moisture. •Discard the remainder. Do not store them. Ask the pharmacist how to discard. Chugai Pharmaceutical Co., Ltd.Internal Revised: 5/2007 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.