英文药名：Kogenate-FS BIO-SET(Octocog alfa[genetical recombination])

中文药名：基因重组辛凝血素α注射剂

日文药名：コージネイトFS バイオセット注

生产厂家：拜耳药品
治疗类别名称
重组凝血因子VIII
商標名
Kogenate-FS BIO-SET
一般名
オクトコグ　アルファ（遺伝子組換え）
〔Octocog alfa（genetical recombination）〕JAN
本質
ヒトT細胞ハイブリドーマのmRNAに由来するヒト第VIII因子cDNAの発現により，ベビーハムスター腎細胞で産生される2,332個のアミノ酸残基からなる糖蛋白質（分子量：300,000～350,000）
操作注意事项
记录维护
药物是从对应于一个特定的生物制品，施用或订这种药物，药名（商品名），序列号（批号）时，施用或处方日期，接收的管理或处方病人的姓名，地址或类似的记录和存储了至少20年。
适应病症
凝血因子VIII缺乏症患者中，补充血液凝血因子VIII在血浆中，抑制其出血倾向。
用法用量
本剂溶液，静脉注射或滴注逐渐解除这种药物。喷射率，以避免超过每分钟5毫升。剂量通常给药一次每10至30国际单位的身体重1kg，适当增加或根据条件减少。
包装规格
注射瓶/套
250IU、500IU 1000IU×1小瓶[（日本药典注射用水2.5mL）中与一个预填充注射器×1注射器]
[保存过滤PSV组（针带翅膀）作为辅助，Suwaba（酒精棉），附上处置石膏和包]

2000IU×1小瓶[（日本药典注射用水5mL）中与一个预填充注射器×1注射器]
[保存过滤PSV组（针带翅膀）作为辅助，Suwaba（酒精棉），附上处置石膏和包]

制造厂商
拜耳药品社有限公司
注：以上中文资料仅供参考，使用以原处方为准

Kogenate-FS BIO-SET 250（コージネイトFSバイオセット注250） 
Brand name : Kogenate-FS BIO-SET 250
　Active ingredient: Octocog alfa(genetical recombination)
　Dosage form: injection
　Print on wrapping:
Kogenate-FS BIO-SET 500（コージネイトFSバイオセット注500）
Brand name : Kogenate-FS BIO-SET 500
　Active ingredient: Octocog alfa(genetical recombination)
　Dosage form: injection
　Print on wrapping:
Kogenate-FS BIO-SET 1000（コージネイトFSバイオセット注1000）
Brand name : Kogenate-FS BIO-SET 1000
　Active ingredient: Octocog alfa(genetical recombination)
　Dosage form: injection
　Print on wrapping:
Kogenate-FS BIO-SET 2000（コージネイトFSバイオセット注2000）
Brand name : Kogenate-FS BIO-SET 2000
　Active ingredient: Octocog alfa(genetical recombination)
　Dosage form: injection
　Print on wrapping: 
Effects of this medicine
This medicine prevents the state of prolonged bleeding by supplementing blood coagulation factor VIII, one of the factors that promote blood clotting.
It is usually used to suppress a bleeding tendency in patients with blood coagulation factor VIII deficiency.
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>>
•In general, dissolve this medicine with 5 mL of the accompanying solvent, and administer the medicine intravenously via slow injection or drip infusion. Inject the medicine at a rate no greater than 5 mL/min. In general, inject 10 to 30 IU per kg of body weight at a time. The dosage may be adjusted according to your symptoms. Strictly follow the instructions.
•Injections should take more than a minute per preparation.
•Make sure that this medicine has completely dissolved before injecting. Inject this medicine immediately after it has dissolved (within 3 hours).
•If you miss a dose, you should never inject two doses to make up for the missed dose. Consult with your doctor/pharmacist and follow the instructions.
•If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop injecting 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 rash, hives, itch, and injection site 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.
•hives, swelling of lips, and shortness of breath [anaphylaxis]
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 at 2 to 8 degrees Celsius (in the refrigerator) and avoid freezing. It is desirable to store in the refrigerator but it can also be stored at room temperature (lower than 25 degrees Celsius). Once stored at room temperature, use the medicine within 6 months and do not store it back in the refrigerator.
•Do not discard expired medicines or used containers and kits after injecting at home. Return them to your clinic/hospital on your next visit.
•Do not massage the site of injection.
Bayer Yakuhin, Ltd.Self-injection
Revised: 12/2014
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.
1）：http://di-pedia.com:808/DIC_GOOCO/Attach/6343430G1026_1_16.html
2）：http://www.info.pmda.go.jp/go/pack/6343430G4025_1_08/