Novo-Nordisk A/S (NVO)获得FDA批准第一种治疗血友病人流血意外的稳定崇组产品。 通用名：注射用重组人凝血因子VIIa 商品名：诺其®（NovoSeven®） 英文名：Recombinant Human Coagulation VII for Injection (Eptacog alfa，activated) 成份及组成:重组人凝血因子VIIa 60 KIU(1.2 mg） 性状：本品为冻干制剂，为白色疏松体，无融化迹象。按标示量加入灭菌注射用水溶解后应为澄清无色液体，无味、无肉眼可见异物、无浑浊和沉淀。 【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】应在出血发作开始后尽早给予本品。静脉推注给药，推荐起始剂量为90g/每公斤体重。初次注射本品后可能需再次注射。疗程和注射的间隔将随出血的严重性、所进行的有创操作或外科手术而不同。 【不良反应】根据上市后用药-验，药物不良反应罕见。具体请参见说明书。 【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。 【有效期】36个月。 【贮藏】本品应存放于2℃-8℃（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。 Medication nameNovoSeven RT approved for hemophilia A or B NovoSeven RT 8mg vial approved for hemophilia A or B The FDA has approved NovoSeven RT (coagulation Factor VIIa [recombinant] room temperature stable, from Novo Nordisk) in an 8mg vial size. The 8mg vial allows a rapid initiation and administration of NovoSeven RT for those who need a larger dose. In addition, the FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature. NovoSeven RT is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency. NovoSeven RT is already available in 1mg, 2mg, and 5mg vials. The 8mg vial size is expected to be available in November 2010 Generic name: Factor Viia, Recombinant - Injection Pronunciation: (factor VIIA,ree-KOM-bin-unt) Brand name(s): Novoseven Uses This medication is used to treat and prevent bleeding in people with certain conditions (hemophilia type A or B patients with antibodies/inhibitors that reduce the activity of clotting factors VIII or IX). It may also be used to treat and prevent bleeding episodes in people born with low levels of factor VII. People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. How to use This medication is given by injection into a vein usually over several minutes. The dose is usually repeated every 2 to 6 hours or as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment.Do not inject the mixing solution (sterile water for injection) directly into the medication powder because this may cause the medication to become ineffective. Aim the syringe so that the water flows gently down the side of the vial. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Do not mix this medication with any other drugs. Use immediately.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Tell your doctor if your condition does not improve or if it worsens. Precautions Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious infection in the blood, recent serious injury.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, consult your doctor before breast-feeding. Drug interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This product should not be given at the same time as certain other clotting factor products (activated and non-activated prothrombin complex concentrates). Side effects Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, new or worsening bleeding/bruising, new or worsening joint pain/swelling.Get medical help right away if any of these rare but very serious side effects occur: pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, fast/slow heartbeat, sudden vision changes, weakness on one side of the body, slurred speech, confusion, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Notes Do not share this medication with others.Laboratory and/or medical tests (e.g., clotting time tests, factor VII activity) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Medical alert Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Storage Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Photos by medication strength Click the "Photos" link to see sample photographs for a specific medication strength. Common strengths Novoseven RT 1 mg (1,000 mcg) IV Solution Novoseven RT 2 mg (2,000 mcg) IV Solution Novoseven RT 5 mg (5,000 mcg) IV Solution Novoseven RT 8 mg (8,000 mcg) IV Solution *The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Important note HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Information last revised April 2012. Copyright(c) 2012 First Databank, Inc. Intravenous Recon Soln Coagulation Factor VIIa Recomb| Hemorrhaging in Hemophilia A|Hemorrhaging in Hemophilia B|Congenital Factor VII Deficiency|Hereditary Hypoproconvertinemia|Bleeding Prophylaxis in Hemophilia|Hemorrhage Prophylaxis in Hemophilia| Bleeding in Hemophilia A|Bleeding in Hemophilia B|Hereditary Factor VII Deficiency Syndrome|Bleeding Prevention in Hemophilia| Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. 附件: 201112121303425.PDF --------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买时以咨询为准！ --------------------------------------------------------------- 产地国家：美国 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 -------------------------------------------------------------- 产地国家：美国 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 -------------------------------------------------------------- 产地国家：美国 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 -------------------------------------------------------------- 产地国家：美国 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 相关资料附件1：http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=26978