英文药名：THROMBIN Oral Fine Granules（Thrombin）

中文药名：凝血酶口服微粒

生产厂家：泽井药业

経口用トロンビン細粒5千単位／経口用トロンビン細粒1万単位

治疗类别名称
上消化道的止血剂
商標名
THROMBIN
一般名
トロンビン(Thrombin)
性状
凝血酶是白色MuAkirakatachi的物质为淡黄色。当你溶于生理盐水为1.0mL每500个单位量，融化到一个明确的或在1个轻微浑浊分钟。
操作注意事项
稳定性试验
小袋包装那些加速试验（40℃75％RH，6个月），为使用的结果，据推测，在正常市场分配一个三年稳定性。
适应病症
上消化道出血
用法与用量
在一个合适的缓冲剂溶液（200-400单位/mL凝血酶）口服给药。该剂量可根据出血部位和程度进行调整。
药效药理
1. 凝血酶的是参与血液凝固过程的最后阶段的纤维蛋白原酶水解产生的血纤维蛋白单体。血纤维蛋白单体自动成为聚合和聚合纤维蛋白凝块，通过共价键的血纤维蛋白分子结合的行为被进一步活化血液凝固因子XIII，以形成稳定的纤维蛋白。
2. 在纤维蛋白原血，迅速凝块出血局部的血液通过凝血酶的作用以关闭受损血管端，完全止血原始凝结的血小板收缩血管残端的存在到。
3. 凝固速度取决于凝血酶溶液的浓度。
包装规格
細粒
5000单位：30包（1包0.5克）
10000单位：30包（1包1G）
200单位：30包（1包2G）

*制造厂商
泽井药业有限公司
細粒
0.5g（5,000単位）：10包、30包

1g（10,000単位）：10包、30包

*制造厂商
持田制药有限公司
1）：http://www.info.pmda.go.jp/go/pack/3323001C1053_1_05/
2）：http://www.info.pmda.go.jp/go/pack/3323001C1061_1_04/
THROMBIN Oral Fine Granules 10,000 Units（経口用トロンビン細粒1万単位）
Brand name : THROMBIN Oral Fine Granules 10,000 Units
　Active ingredient: Thrombin
　Dosage form: white fine granules
　Print on wrapping: 経口用トロンビン細粒, 1 g, 1万単位
Effects of this medicine
This medicine is an enzyme related to blood coagulation and has the effect to stop bleeding from tissue surface.
It is usually used to treat upper gastrointestinal bleeding.
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>>
•Gastric acid needs to be neutralized using a buffering agent (milk, phosphate buffer solution, etc.) before this medicine is taken. First, take approximately 50 mL of the buffering agent. Five minutes later, take this medicine after dissolving 1 to 2 packets (10,000 to 20,000 units of the active ingredient) with approximately 50 mL of the buffering agent. However, the dosage may be adjusted according to the sites and severity of bleeding. Strictly follow the instructions.
•Take this medicine immediately after opening the packet and dissolving with the buffering agent. The solution may become slightly cloudy, but the effect of this medicine will not be affected.
•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. 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
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include abdominal bloating, diarrhea, nausea, vomiting, fever, rash, redness and headache. 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.
•respiratory distress, bluish purple to dark purple discoloration of the skin and mucosa (especially lips and nails of limbs), dizziness on standing up [shock]
•prolonged bleeding, bleeding tendency [clotting disorder, abnormal bleeding]
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 direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Sawai Pharmaceutical Co.,Ltd.Internal
Revised: 10/2008
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.