英文药名:Desferal for injection(Deferoxamine Mesilate)
中文药名:甲磺酸去铁胺注射液
生产厂家:诺华制药
デスフェラール注射用500mg
类别名称
铁排泄剂
商標名
Desferal for injection
構造式
一般名
デフェロキサミンメシル酸塩(Deferoxamine Mesilate)
化学名
N-[5-(Acetylhydroxyamino)pentyl]-N'-(5-{3-[(5-aminopentyl)hydroxycarbamoyl]-propanoylamino}pentyl)-N'-hydroxysuccinamide monomethanesulfonate
分子式
C25H48N6O8・CH4O3S
分子量
656.79
性状
白色至浅黄色结晶性粉末。易溶于水,乙醇(99.5),可溶于2-丙醇或乙醚很差。
熔点:约147℃(分解)
药效药理
1. 与三价铁离子结合,以形成一个稳定的水溶性ferrioxamine B.其稳定性常数是1031,比EDTA(1025)(体外)更强。从理论上讲是甲磺酸去铁胺100毫克与3价铁离子结合8.5mg。
2. 除去从铁蛋白和含铁血黄素铁,不与铁血红蛋白(体外),据信不与肌红蛋白的卟啉铁或在酶呼吸系统反应反应。此外,没有铁大部分从在体内转铁除去。
3. 与在肝实质细胞铁蛋白或含铁血黄素铁相结合,是通过胆汁排泄,是细胞结合的铁从网络内细胞衍生的肝之外,但是通过肾脏排泄,铁在肝细胞外键仅后转的铁结合容量饱和度(大鼠)识别。
适应病症
铁尿在下列疾病的排出量增加
原发性血色病
继发性血色病
用法用量
本剤1小瓶(去铁胺甲磺酸酯500毫克),使用溶解在日本药典注射用水5mL的。一般,对于慢性铁过载疾病,注入1000毫克,为单一的每日剂量去铁胺甲磺酸盐肌内分为1-2次。作为维持剂量,这取决于影响表达的程度,减肥500毫克适当每日剂量去铁胺甲磺酸酯。
当患者具有特别的或严重的,或休克状态,逐渐分配以每小时为15mg/ kg的速率滴注1000毫克,因为一旦去铁胺甲磺酸酯,每日剂量不超过80毫克/千克的范围内。
包装规格
注射用:500毫克:5瓶
制造商
诺华制药有限公司
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/3929402D1036_1_08/
Desferal for injection 500mg(デスフェラール注射用500mg)
Brand name : Desferal for injection 500mg
Active ingredient: Deferoxamine mesilate
Dosage form: injection
Print on wrapping:
Effects of this medicine
This medicine is an iron chelator agent which binds and excretes excessively accumulated iron from the body into the urine or stool.
It is usually used to treat hemochromatosis (organ damage caused by excess iron).
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 not able to urinate.
If you have renal/hepatic disorder or diabetes.
•If you are pregnant, breastfeeding or possibly pregnant.
•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>>
•In general, inject it intramuscularly 1 to 2 times a day. It may be administered intravenously at a slow speed
•Ask your doctor about your treatment span.
Precautions while taking this medicine
•This medicine may cause dizziness or visual/hearing impairment. Avoid driving a car or operating dangerous machinery if you have such symptoms.
•When this medicine binds with iron and is excreted in the urine, your urine may turn to a characteristic reddish color.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hepatic dysfunction, malaise, visual disorder, skin disorders such as rash/erythema/urticaria, hearing disorder such as hearing loss and bone pain. 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.
•urticaria, dyspnea, swelling around eyes/lips [shock, anaphylactoid symptoms]
•blurred vision, reduced visual acuity, unable to see color difference [eye disorder]
•hearing difficulty of voice or sound, tinnitus [hearing disorder]
•fever, diarrhea, abdominal pain [infection with Yersinia (bacterial infection)]
•fever, cough, sputum [infection with Mucormycosis (fungal infection)]
•decrease of urine volume, edema, thirst [acute renal failure, renal tubular disorders]
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.
Novartis Pharma K.K.Injection
Revised: 3/2015
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.