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Onealfa Solution(阿法骨化醇口服液)

2016-02-17 06:48:38  作者:新特药房  来源:互联网  浏览次数:7  文字大小:【】【】【
简介:英文药名:Onealfa Solution(Alfacalcidol) 中文药名:阿法骨化醇口服液 适合病症:骨质疏松症、慢性肾功能衰竭、甲状旁腺功能减退症等 生产厂家:帝人制药 ワンアルファ内用液0.5μg/mL 治疗类别名称活 ...

英文药名:Onealfa Solution(Alfacalcidol)

中文药名:阿法骨化醇口服液

适合病症:骨质疏松症、慢性肾功能衰竭、甲状旁腺功能减退症等

生产厂家:帝人制药

ワンアルファ内用液0.5μg/mL

治疗类别名称
活性维生素D3制剂
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
白色晶体或结晶粉末,甲醇,乙醇(99.5),易溶于氯仿,二氯甲烷,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。
适应病症
1. 在下列疾病的维生素D代谢异常(低钙血症,手足抽搐,骨痛,骨病变等)的改进有关的各种症状
(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性佝偻病,软骨病
2. 骨质疏松
用法与用量
这种药物,向患者的血清钙浓度的原始适当管理,调整剂量。
(1) 慢性肾功能衰竭,在骨质疏松症的情况下
成人每天口服给药0.5〜为1.0μg。然而,为了增加或减少取决于患者的年龄和症状。
(2) 甲状旁腺功能减退,在与疾病其它维生素D代谢异常的情况下
成年人口服给药每天一次1.0〜4.0μg。然而,剂量可根据病情,患者的年龄,症状,疾病的类型进行调整。
(小児用量)
每天一次0.05〜0.1微克/千克至0.01〜0.03μg/ kg,在其它疾病的情况下,在骨质疏松症的儿童的情况下,也曾经0.008〜0.1微克/早产儿公斤1日口服。然而,剂量可根据病情,症状进行调整。
包装规格
10毫升(褐色玻璃瓶)


制造厂商
帝人制药有限公司
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/3112001S1053_1_04/
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.

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