部份中文奥扎格雷处方资料(仅供参考)
药品英文名
Ozagrel
药品别名
奥扎格雷素、奥泽格瑞、Sodium Ozagrel、Unblot
药物剂型
注射剂:20mg。
药理作用
本药能选择性地抑制血栓烷合成酶,从而抑制血栓烷A2的产生和促进前列环素(PGI2)的产生,改善二者间的平衡,最终抑制血小板聚集和减轻血管痉挛,改善大脑局部缺血时的微循环和能量代谢障碍。
药动学
本药单次静脉注射后,在血中的清除较快;连续静脉注射后,2h达到稳定血药浓度。该药在血中的主要成分除其游离形式外,还有其β-氧化体和还原体。本药大部分在24h内排泄,其代谢物几乎没有药理活性。动物试验未发现本药有蓄积性和毒性。
适应证
1.主要用于改善脑血栓症(急性期)的运动障碍。
2.改善蛛网膜下腔出血手术后的脑血管痉挛状态及伴随产生的脑缺血症状。
禁忌证
1.有过敏史者。
2.有出血性脑梗死、硬膜外出血、颅内出血或并发有原发性脑室内出血的患者。
注意事项
1.慎用:
(1)消化道出血、皮下出血者;
(2)血小板减少、重症高血压、重症糖尿病等有出血倾向者;
(3)使用抗血小板药、血栓溶解剂、抗凝血剂者;
(4)孕妇。
2.应避免本药与含钙溶液(如林格溶液等)混合使用,以免溶液发生混浊。
不良反应
1.常见的不良反应为恶心、呕吐、腹泻等胃肠道反应。
2.较少发生出血性脑梗死、硬膜外血肿、颅内出血、消化道出血、皮下出血等病症。
3.偶可引起休克、血小板减少、贫血、肝脏氨基转移酶升高。
用法用量
静脉滴注:
1.改善脑血栓症(急性期):每次给药40~80mg,溶解于电解质液或糖溶液中,每次滴注须持续2h,每天2次,连用1~2周,必要时可酌情减量。
2.改善蛛网膜下腔出血手术后的脑血管痉挛状态及伴随产生的脑缺血症状:每天给药80mg,溶解于电解质液或葡萄糖溶液中,24h连续滴注,连用2周。可根据年龄及症状酌情调整剂量。
药物相应作用
本药与其他抑制血小板功能的药物合用时有协同作用,故本药剂量应酌减。
XANBON injectable(Ozagrel sodium)
XANBON injectable 20mg [cerebral thrombosis](キサンボン注射用20mg[脳血栓症/くも膜下出血術後])
Brand name : XANBON injectable 20mg [cerebral thrombosis]
Active ingredient: Ozagrel sodium
Dosage form: injection
Print on wrapping
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XANBON injectable 40mg [cerebral thrombosis](キサンボン注射用40mg[脳血栓症/くも膜下出血術後])
Brand name : XANBON injectable 40mg [cerebral thrombosis]
Active ingredient: Ozagrel sodium
Dosage form: injection
Print on wrapping:
Effects of this medicine
This medicine suppresses production of thromboxane A2 and promotes production of prostacyclin by selectively inhibiting thromboxane synthetase, leading to improvements in the imbalance between thromboxane A2 and prostacyclin, as well as to antiplatelet aggregation action.
It is usually used to improve paralysis of limbs associated with cerebral thrombosis in the acute phase, during which the blood vessels in the brain get clogged.
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 have bleeding (hemorrhagic cerebral infarction, epidural bleeding, intra-cerebral bleeding, primary intraventricular bleeding), brain embolism, heart problems, cortical symptoms such as disturbance of consciousness or speech loss/agnosia or cardioembolic stroke.
•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>>
•In general, inject intravenously for 2 hours twice a day in the morning and evening.
•In general, inject every day for 2 consecutive weeks.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include liver dysfunction, hemorrhagic adverse reactions (hemorrhagic cerebral infarction/cerebral bleeding/gastrointestinal bleeding/subcutaneous bleeding, etc.), rash, anemia, asthma (like) attack, itch, hives, erythema and blood pressure decreased. 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.
•headache, bloody stool, subcutaneous bleeding [bleeding]
•blood pressure decreased, respiratory distress, pharyngeal edema [shock, anaphylactoid symptoms]
•yellow discoloration of the skin and the white of eyes, general malaise, loss of appetite [liver dysfunction, jaundice]
•prolonged bleeding, gum bleeding, bruise [platelets decreased]
•fever, sore throat, general malaise [white blood cell decreased, granulocytopenia]
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.
Kissei Pharmaceutical Co., Ltd.Injection
Revised: 8/2012
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.
http://www.info.pmda.go.jp/go/pack/3999411D1064_1_08/
附件:20127320471932.PDF
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产地国家:日本
原产地英文商品名:
XANBON(キサンボン注射用) 40MG/VIAL 10VIALS/BOX
原产地英文药品名:
OZAGREL SODIUM
中文参考商品译名:
XANBON(キサンボン注射用) 40毫克/瓶 10瓶/盒
中文参考药品译名:
奥扎格雷钠
生产厂家中文参考译名:
日本橘生制药
生产厂家英文名:
Kissei
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产地国家:日本
原产地英文商品名:
XANBON(キサンボン注射用) 20MG/VIAL 10VIALS/BOX
原产地英文药品名:
OZAGREL SODIUM
中文参考商品译名:
XANBON(キサンボン注射用) 20毫克/瓶 10瓶/盒
中文参考药品译名:
奥扎格雷钠
生产厂家中文参考译名:
日本橘生制药
生产厂家英文名:
Kissei