英文药名：Onealfa Solution(Alfacalcidol) 中文药名：阿法骨化醇口服液 生产厂家：帝人制药 ワンアルファ内用液0.5μg/mL 药物分类名称 活性维生素D3配方 批准日期：2009年9月 商標名 Onealfa Solution 0.5μg/mL 一般名 アルファカルシドール（Alfacalcidol） 化学名 (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β-diol 化学構造式 分子式 C27H44O2 分子量 400.64 融点 137～142℃ 性状 它是白色晶体或结晶粉末，易溶于甲醇，乙醇（99.5），氯仿或二氯甲烷，微溶于丙酮或乙醚，几乎不溶于水或己烷。 它随着空气或光线而变化。 药效药理 这种药物，通过从口服给药的肠肝微粒体后所吸收的血液迅速25羟化酶侧链的25位上是氢氧化活性表达剂1α，25-（OH）2D3和肠和骨等钙吸收促进分布式在靶组织中的受体结合肠的效应，表达一系列生理活性等的骨矿物质溶解作用和骨形成作用。 （1）钙的吸收和血清钙从肠道增加作用 维生素d-缺陷大鼠和肾切除大鼠实验施用阿法骨化醇对，钙吸收促进肠道的效果，血清钙水平增加作用已被观察到。 （2）骨形成促进作用 1）骨组织培养 胎儿组织培养，将其从9天蛋取出，在正常的骨形成1α的研究，25-（OH）2D3已经被证明是重要的。 2）肾切除大鼠 集纳全子宫切除术，许多骨吸收腔和骨样层，将大鼠低矿化层显着增加，在实验中，阿法骨化醇30天给药，已经观察到新骨。 3）骨质疏松症模型大鼠（卵巢切除大鼠） 血液1α卵巢切除长育种，25-（OH）在还原或松骨小梁和2D3值的钙化率的降低发生，这些变化阿法骨化醇0.1微克/kg/天，6个月给药它是由改善。 4）骨质疏松症模型大鼠（氢化可的松处理的大鼠） 松骨小梁通过氢化可的松长期给药，骨皮质宽度，在骨组件的减少出现时，这些变化阿法骨化醇0.02微克/kg/天〜0.1微克/kg/天，为12周的改善。 5）老年性骨质疏松（人，电子显微镜，光学显微镜观察） 进行髂骨活检之前和之后施用一种α-胶囊剂，进行了电子显微镜，光学显微镜观察，如增加的成骨细胞的活性，骨细胞，骨矿化腔隙，组织学骨观察到的改善。 6）的Ca摄入和骨吸收，骨形成活性 改变维生素d-缺乏大鼠饮食中的Ca含量，在实验中，施用阿法骨化醇，出现骨吸收当Ca含量较少，如果Ca含量是足以显着地出现的成骨。 适应症 1.改善与下列疾病中维生素D代谢异常相关的各种症状（低钙血症，手足搐痛，骨痛，骨病变等） （1）慢性肾功能衰竭 （2）甲状旁腺功能减退症 （3）早产儿 （4）维生素D耐药库鲁病·骨软化症 2.骨质疏松症 用法与用量 在充分控制患者的血清钙浓度的情况下调节该药物的剂量。 （1）在慢性肾功能衰竭的情况下，骨质疏松症 通常，0.5至1.0μg作为阿法骨化醇口服给予成人每日一次。但是，它会根据您的年龄和症状而增加或减少。 （2）甲状旁腺功能减退症和其他与维生素D代谢紊乱有关的疾病 通常，成人每天口服1.0至4.0μg阿法骨化醇。但是，应根据疾病，年龄，症状和疾病类型增加或减少。 （小儿剂量） 通常对于儿童，在骨质疏松症的情况下，每天一次使用0.01至0.03μg/kg的阿法哌啶醇，在其他疾病的情况下，每天一次使用0.05至0.1μg/ kg的阿尔法哌啶醇 ，并且早产儿每天口服施用0.008至0.1μg/kg。但是，应根据疾病和症状增加或减少。 包装规格 10毫升（包括棕色玻璃瓶） 制造供应商 帝人制药公司 注：以上中文资料不够完整，使用者以原处方资料为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/3112001S1053_1_05/ Onealfa Solution 0.5mcg/mL（ワンアルファ内用液0.5μg/mL）  Brand name : Onealfa Solution 0.5mcg/mL 　Active ingredient: Alfacalcidol 　Dosage form: colorless to light yellow oral solution 　Print on wrapping:  Effects of this medicine This medicine becomes active vitamin D3 in the liver and acts on the intestine and bone, etc., to promote intestinal calcium absorption, dissolve bone minerals and form bones. It is usually used to improve various symptoms (hypocalcemia, tetany, bone pain, bone lesion, etc.) associated with abnormal vitamin D metabolism in patients with chronic renal failure, hypoparathyroidism and vitamin D-resistant rickets/osteomalacia and in immature infants, and to treat osteoporosis. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •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 <<to be written by a healthcare professional>> •For osteoporosis: In general, for adults, take 1 to 2 mL (0.5 to 1.0 mcg of the active ingredient) at a time, once a day. For children, take 0.02 to 0.06 mL/kg (0.01 to 0.03 mcg/kg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the age/symptoms. For chronic renal failure: In general, for adults, take 1 to 2 mL (0.5 to 1.0 mcg of the active ingredient) at a time, once a day. For children, take 0.1 to 0.2 mL/kg (0.05 to 0.1 mcg/kg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the age/symptoms. For hypoparathyroidism, vitamin D resistant rickets/osteomalacia: In general, for adults, take 2 to 8 mL (1.0 to 4.0 mcg of the active ingredient) at a time, once a day. For children, take 0.1 to 0.2 mL/kg (0.05 to 0.1 mcg/kg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the disease to be treated, age/symptoms or the type of disease. For immature infants: Take 0.016 to 0.2 mL/kg (0.008 to 0.1 mcg/kg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the symptoms. In any case, strictly follow the instructions. •Measure the dose accurately with a dropper before taking this medicine. •If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •Do not take any over-the-counter medicines or dietary supplements containing a large amount of calcium or vitamin D without consulting with your doctor. Excessive intake of calcium and vitamin D would be of concern. Possible adverse reactions to this medicine The most commonly reported adverse reactions include itch, nausea, loss of appetite, diarrhea, constipation, gastric pain, conjunctival hyperemia and rash. If any of these symptoms occur, consult with your doctor or pharmacist. 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 urine output, edema, general malaise [acute renal failure] •general malaise, loss of appetite, yellowness in the skin or whites of the eyes [liver 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 away from heat, moisture and light. •Discard the remainder. Do not store them. Ask the pharmacist or medical institution how to discard them. TEIJIN PHARMA LIMITEDInternal Revised: 11/2014 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.