部分中文NovoSeven RT处方资料（仅供参考）

Novo-Nordisk A/S (NVO)获得FDA批准销售NovoSeven RT，这是第一种治疗血友病人流血意外的稳定崇组产品。

【药品名称】诺其 NovoSeven

【通 用 名】注射用重组人凝血因子VIIa

【适 应 症】用于下列患者群体的出血发作及预防; 在外科手术过程中或有创操作中的出血。 
·凝血因子Ⅷ或Ⅸ的抑制物〉5BU的先天性血友病患者； 　
·预计对注射凝血因子Ⅷ或凝血因子 Ⅸ,具有高记忆应答的先天性血友病患者；
·获得性血友病患者； 
·先天性FVII缺乏症患者； 
·具有GP II b-IIIa和/或HLA抗体和既往或现在对血小板输注无效或不佳的血小板无力症患者。

【用法用量】诺其-治疗推荐的标准剂量为90～120mcg/kg，初始时每间隔2小时予此剂量输注，然后逐渐延长给药间隔。临床研究证实，存在有抑制物的患者，无论是存在有同种异体抗体的血友病A和血友病B患者，还是存在有自身抗体的获得性血友病患者，诺其90 mcg/kg的剂量均可有效（有效率80～90％）并且安全地确保止血。

【不良反应】
罕见严重的不良反应，但有异常情况时，请与医生联系。极少的情况下可能会出现出血、皮疹和发烧。产品上市后发生过的严重不良反应有：
1、动脉血栓事件：如心肌梗塞或缺血，脑血管疾患和肠梗塞。所有这些患者均由于年龄、动脉硬化病史或现患有“特殊警告及特殊注意事项”中所列疾病而具有血栓性疾病倾向。
2、静脉血栓事件：如肺栓塞及血栓静脉炎。所有这些患者均由于年龄、手术后卧床或中心静脉导管而具有栓塞性疾病倾向。患者因年龄、既往栓塞史（动脉硬化病史、手术后卧床或中心静脉导管史）而具有栓塞性疾病倾向，用药时应密切监察。
3、出血：严格按照“用量”项下所推荐的剂量注射者无一例引起出血的报告。
在临床试验中有凝血异常如血小板计数降低，纤维蛋白原减少和出现D-二聚体的报告。除一例病例外，没有出现与凝血异常相关的临床症状。这一特殊的病例由于肌坏死，具有弥散性血管内凝血倾向。具有弥散性血管内凝血倾向的患者，用药时应密切监察。
上市至今，有一例没有临床症状的凝血异常病例报告。
在包含血小板减少症患者的临床试验中，有一例过敏反应报告。这名患者对其它几种药品有过敏反应史，在接受重组人凝血因子Ⅶa治疗后发生了过敏反应。上市至今，没有过敏反应的报告。具有过敏反应史的患者，用药时应密切监察。

【药物相互作用】使用本品前，应咨询医生有关同时使用其它药品的问题。

【注意事项】
使用本品前，如有下列情况，请告知医生：
1、刚做过外科手术；
2、患有挤压性损伤；
3、患有血栓形成性疾病或进行性动脉粥样硬化性疾病；
4、患有败血症。
重度出血者须到医院注射本药。
轻度或中度出血者可在家里注射重组人凝血因子VIIa（NovoSeven），应立即向医生或医院汇报重组人凝血因子Ⅶa的使用剂量和效果（如：电话联系）。必要时与血液科专家保持密切联系。
如果用药24小时后，出血未得到控制，则不能再继续在家治疗，应到医院就诊。
将本品置于远离儿童的地方。

【禁 忌】
对本品中含有的活性成份，赋形剂，或小鼠、仓鼠或牛蛋白过敏者禁用。

【孕妇及哺乳期妇女用药】妊娠妇女应在有明确需要时才使用本品。若正在哺乳,应停止哺乳或停止用药。

【贮 藏】
本品应存放于2oC-8oC（冰箱中）；在-包装盒内避光保存；请勿冰冻以免损坏溶剂瓶；最好配制后立即使用；请勿将配制好的重组人凝血因子VIIa(NovoSeven）持续储存在注射器中。

Brand Names: NovoSeven, NovoSeven RT

Generic Name: coagulation factor VIIa (injection) (Pronunciation: koe AG yoo LAY shun FAK tor )

What is coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Coagulation factor VIIa is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor VIIa is used to treat or prevent bleeding in people with hemophilia A or hemophilia B, or factor VII deficiency.

Coagulation factor VIIa may also be used for other purposes not listed in this medication guide.

What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:
fever;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance; or
pain or swelling in one or both legs.

Less serious side effects may include:
headache;
joint pain;
nausea, vomiting;
swelling;
mild itching or rash; or
pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have coronary artery disease (hardening of the arteries), a history of stroke or heart attack, a severe injury or infection, or if you are allergic to mouse, hamster, or pork proteins.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.

What should I discuss with my healthcare provider before using coagulation factor VIIa (NovoSeven, NovoSeven RT)?
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using coagulation factor VIIa, tell your doctor if you have:
coronary artery disease (hardening of the arteries);
a history of stroke or heart attack;
a severe injury or infection; or
if you are allergic to mouse, hamster, or pork proteins.

FDA pregnancy category C. Coagulation factor VIIa may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether coagulation factor VIIa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Coagulation factor VIIa is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You may need to mix coagulation factor VIIa with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.

NovoSeven should be stored in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight.

NovoSeven RT may be stored at cool room temperature away from moisture, heat, and light.

After mixing NovoSeven RT with a diluent, you may keep it at room temperature or in the refrigerator and use it within 3 hours. Do not freeze or store the mixture in a syringe.

What happens if I miss a dose (NovoSeven, NovoSeven RT)?
Contact your doctor if you miss a dose of this medication.

What happens if I overdose (NovoSeven, NovoSeven RT)?
Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of coagulation factor VIIa is not expected to produce life-threatening symptoms.

What should I avoid while using coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

What other drugs will affect coagulation factor VIIa (NovoSeven, NovoSeven RT)?
Tell your doctor about all other medications you use, especially medications used to treat severe bleeding episodes, such as:
aminocaproic acid (Amicar); or
tranexamic acid (Cyklokapron).

This list is not complete and there may be other drugs that can interact with coagulation factor VIIa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about coagulation factor VIIa.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

--------------------------------------------------------------
原产地英文商品名:
NOVOSEVEN RT 8000mcg/vial
原产地英文药品名:
FACTOR VIIA,RECOMB(BHK CELLS)
中文参考商品译名:
诺其 RT 8000微克/瓶
中文参考药品译名:
重组人凝血因子VIIA,RECOMB(BHK细胞)
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
Novo Nordisk
--------------------------------------------------------------
原产地英文商品名:
NOVOSEVEN RT 2000mcg/vial
原产地英文药品名:
FACTOR VIIA,RECOMB(BHK CELLS)
中文参考商品译名:
诺其 RT 2000微克/瓶
中文参考药品译名:
重组人凝血因子VIIA,RECOMB(BHK细胞)
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
Novo Nordisk

--------------------------------------------------------------
原产地英文商品名:
NOVOSEVEN RT 5000mcg/vial
原产地英文药品名:
FACTOR VIIA,RECOMB(BHK CELLS)
中文参考商品译名:
诺其 RT 5000微克/瓶
中文参考药品译名:
重组人凝血因子VIIA,RECOMB(BHK细胞)
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
Novo Nordisk
--------------------------------------------------------------
原产地英文商品名:
NOVOSEVEN RT 1000mcg/vial
原产地英文药品名:
FACTOR VIIA,RECOMB(BHK CELLS)
中文参考商品译名:
诺其 RT 1000微克/瓶
中文参考药品译名:
重组人凝血因子VIIA,RECOMB(BHK细胞)
生产厂家中文参考译名:
诺和诺德
生产厂家英文名:
Novo Nordisk