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Bortezomib Injection 1Vial×3mg(硼替佐米静注液「NK」)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 3毫克/瓶 1瓶/盒 
包装规格 3毫克/瓶 1瓶/盒 
计价单位: 瓶 
生产厂家中文参考译名:
日本化药
生产厂家英文名:
Nippon Kayaku Co.Ltd
该药品相关信息网址1:
https://www.drugs.com/mtm/bortezomib.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Bortezomib(ボルテゾミブ注射用「NK」)3mg/Vial 1Vial/box
原产地英文药品名:
Bortezomib
中文参考商品译名:
Bortezomib(ボルテゾミブ注射用「NK」)3毫克/瓶 1瓶/盒
中文参考药品译名:
硼替佐米
曾用名:
简介:

 

部份中文硼替佐米处方资料(仅供参考)
商品名:Bortezomib Injection
英文名:Bortezomib
中文名:硼替佐米静注液
生产商:日本化药
药品简介
硼替佐米(Bortezomib)为蛋白酶体抑制剂,是一种靶向治疗药物,用于治疗多发性骨髓瘤及套细胞淋巴瘤等,具有起效快、安全性高(可应用于肾功能不全甚至肾衰患者)等优势。
ボルテゾミブ注射用3mg「NK」
药效分类名称
抗恶性肿瘤剂(蛋白酶体抑制剂)
批准日期:2021年12月
欧文商標名
Bortezomib Injection
一般名:
ボルテゾミブ(Bortezomib)
化学名:
{(1R)-3-Methyl-1-[(2S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido]butyl}boronic acid
分子式:
C19H25BN4O4
分子量:
384.24
構造式:
性状:
本品为白色至微黄白色粉末或块状物。 易溶于甲醇,微溶于乙醇 (99.5)。
处理注意事项
稳定性测试:
作为使用最终包装的加速测试(40°C,75% 相对湿度,6个月)的结果,估计硼替佐米注射液3mg “NK”在正常市场分销下可稳定 3年。
药效药理
Bortezomib通过与肿瘤细胞中26S蛋白酶体的20S核心的β5亚基结合并可逆地抑制糜蛋白酶样活性来诱导细胞凋亡并抑制肿瘤生长。
适应症
○多发性骨髓瘤
○原发性巨球蛋白血症和淋巴浆细胞瘤
用法与用量
1. 多发性骨髓瘤
对于成人,1.3mg/m2(体表面积)的硼替佐米通过以下方法A或B每天一次静脉内或皮下给药。这种药物应至少间隔72小时给药。
方法一:
与其他抗肿瘤药物合用时,应每周给药两次,持续2周(第1、4、8和11天),然后停药10天(第12至21天)。这3周被视为1个周期,重复给药直至2或8个周期。3或9个周期后,每周给药2周(第1天和第8天),停药13天(第9天至第21天)。这3周被视为一个周期,重复给药至多18个周期。应根据联合使用的抗肿瘤药物选择过渡到每周一次给药的时机。
方法B(仅在复发或难治的情况下):
每周给药两次,持续2周(第1、4、8和11天)后,停药10天(第12至第21天)。这3周为一个周期,重复给药。
如果连续给药超过8个周期,则以上述剂量和给药方式继续给药,或每周给药一次,持续4周(第1、8、15、22天)作为维持治疗,持续13天。停药(第23天至第35天)。这5周为一个周期,重复给药。
2.原发性巨球蛋白血症和淋巴瘤细胞瘤淋巴瘤
硼替佐米的成人常用剂量是在第1、4、8和11天静脉内或皮下注射1.3mg/m2(体表面积),然后休息10天(第12-21天)。这3周为一个周期,重复给药。这种药物应至少间隔72小时给药。
包装
1小瓶(小瓶被UV切割膜屏蔽。)
制造厂商
日本化药株式会社
注:以上中文处方资料不够完整,使用者以原处方资料为准!
完整说明资料附件:
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/530191_4291412D1040_1_01
-----------------------------------------
Brand name:Bortezomib for Injection 3mg"NK"
Active ingredient:Bortezomib
Dosage form:injection
Print on wrapping: 
Effects of this medicine
This medicine selectively inhibits proteasome to suppress proliferation of cancer cells.
It is usually used to treat multiple myeloma, primary macroglobulinemia and lymphoplasmacytic lymphoma.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itching, rash, etc.) to any medicines.
If you have a history of pulmonary disorder such as interstitial pneumonia and pulmonary fibrosis.
If you have hepatic disorder, symptoms of peripheral neuropathy (numbness/pain/hot flush in limbs), dehydration or diabetic neuropathy.
If you have a history or risk factor of cardiac disorder.
If you are hepatitis B virus carrier, or negative for HBs antigen and positive for HBc antibody or HBs antibody.
If you have symptoms or have a history of faint.
・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, for adults, inject intravenously or subcutaneously once a day.
・The treatment span depends on the effect of the medicine after using it for a certain period.
Precautions while taking this medicine
・Avoid performing dangerous operations such as driving a car after injection, since this medicine may cause fatigue, dizziness, dizziness on standing up, faint or focus disorder.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include anemia, localized injection site reaction due to subcutaneous injection (erythema/pain/itching at injection site), loss of appetite, diarrhea, rash. constipation, nausea, fever, decreased body weight, peripheral neuropathy, dullness, vomiting, abnormal hepatic function, hypoesthesia, herpes zoster, nerve pain, fatigue and asthenia. 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.
・shortness of breath, chest distress, cough [pulmonary disorder]
・palpitation/shortness of breath, chest pain, leg edema [cardiac disorder]
・restless leg, difficulty in writing, feeling of stepping on an object with many bumps [peripheral nerve disorder]
・fever, bleeding tendency, fatigability/shortness of breath [bone marrow depression]
・constipation, abdominal pain, abdominal bloating, loss of appetite [ileus]
・decreased urine output/bloody urine, decreased consciousness, spasm [tumor lysis syndrome]
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.
Injection
Published: 01/2022
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.

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