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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 药品目录 >> 化疗类 >> 植物类 >> 注射用磷酸依托泊苷 (凡毕复(Etopophos)

注射用磷酸依托泊苷 (凡毕复(Etopophos)

2009-09-13 12:57:05  作者:新特药房  来源:中国新特药网  浏览次数:162  文字大小:【】【】【
简介: 商品名:凡毕复 通用名:依托泊苷注射液 本品为静脉注射用抗肿瘤药物,其单次剂量瓶装含有相当于依托泊苷100 mg的磷酸依托泊苷无菌冻干制剂,和枸橼酸钠32.7 mg,右旋糖酐-40 300 mg。磷酸依托泊苷系鬼 ...
 

 商品名:凡毕复
通用名:依托泊苷注射液

本品为静脉注射用抗肿瘤药物,其单次剂量瓶装含有相当于依托泊苷100 mg的磷酸依托泊苷无菌冻干制剂,和枸橼酸钠32.7 mg,右旋糖酐-40 300 mg。磷酸依托泊苷系鬼臼毒素的半合成衍生物依托泊苷(即 VP-16)水溶性酯。磷酸依托泊苷良好的水溶性降低了因稀释或静注时发生沉淀的可能性。未开瓶盖原包装瓶避光储存于2-8℃(36-46°F)冰箱内。

功用作用:
难治性睾丸肿瘤、小细胞肺癌。

用法用量:

睾丸癌:
合并其他认可的化疗药治疗睾丸癌患者的常用剂量为50-100 mg/m2/日,连续5天,或50-100 mg/m2/日,第1,3,5天给药。小细胞肺癌:与其他认可的化疗药合并用于小细胞肺癌的常用剂量是从35 mg/m207〉2/日,连续4天,或50 mg/m207〉2/日,连续5天。本药输注速率从5-210分钟。化疗疗程之间应相隔3-4周,需等病者从毒性反应中恢复过来。必须考虑到其他合用药物对骨髓的抑制,或者以前可能损及骨髓造血功能储备的放疗或其他化疗药物的影响。 

肾脏损害者:
可按测得的肌酐清除水平调正依托泊苷的初始剂量:肌酐清除率〉 50 mL/分者,给予依托泊苷100%的剂量 ;肌酐清除率为15-50/分钟者,给予75%的剂量。以后的剂量应按病者的耐受程度,以及临床效果适当调整。按与依托泊苷的等效剂量对本药作相应的调整。目前尚无当肌酐清除率低于15 mL/分时的资料,但这些病人需进一步降低剂量。现今尚无用于人体依托泊苷过量的抗毒剂,小鼠单次快速静脉注射依托泊苷120 mg/kg(以mg/m2 计,约为人体剂量的7倍)或更高剂量具致死性,小鼠死亡伴随神经毒性症状。 像对待其他有潜在毒性化合物一样,在拿取以及制备本药溶液过程中,必须十分小心。意外接触本药可能引发皮肤反应。操作时要戴手套。如果本药溶液接触皮肤或粘膜,应立即用肥皂和水彻底刷洗皮肤,粘膜面则用水充分冲洗。

静脉注射用溶液的制备:
使用本品前,小瓶内容应用5 mL或10 mL无菌注射用液、5%葡萄糖液、0.9%氯化钠注射液、苯甲醇抑菌注射液或苯甲醇抑菌注射用氯化钠液重组成相当于依托泊苷20 mg/L或10 mg/L的等效浓度(即磷酸依托泊苷22.7 mg/L或11.4 mg/L)溶液。重组后溶液可不经再稀释直接使用或用5%葡萄糖注射液或0.9%氯化钠注射液进一步稀释后使用,最低浓度可达0.1 mg/mL依托泊苷。
应按无菌操作标准制备本药溶液。只要容器及溶液允许,在注射前,应该以肉眼检查注射用药物溶液是否有颗粒存在或变色。

稳定性:
未打开的原封瓶保存在2-8℃(36-46°F)冷藏条件下,在注明有效期内稳定。按上述方法重组或稀释本药溶液后,在玻璃或塑料容器内,20- 25℃(68-77°F)的室温下或冷藏2-8℃(即36-46°F)条件下可保存24小时。冷藏的本药溶液取至室温下应立即使用。

注意事项:
即往对依托泊苷,磷酸依托泊苷,或本剂中所含其他成分过敏者禁用。 本药用于化疗药物时,医生必须权衡使用本药的必要性和有效性与发生不良反应的危险性之间的利弊。多数不良反应如能早期发现,都是可逆的。严重副反应一旦发生,应减少剂量或停药,并根据医生的临床判断,采取相应的纠正措施。重新采用本药治疗时,必须十分小心,慎密考虑需要的程度,对可能发生的毒性必须高度警惕。血清蛋白低下的病人更易发生依托泊苷有关的毒性。

实验室检验:
在本药治疗期间,应该定期进行全套血细胞计数检查。每个治疗周期前,以及治疗中和治疗后重复血液学检查。   
致癌性、致突变性、对生育力的损害 在本药的体外试验(Ames微生物突变试验和E.coli WP2 uvrA回复突变试验)中,没有显示致突变性。但由于本药在体内迅速而完全地转变成依托泊苷,而Ames试验示依托泊苷具致突变性,因而本药在体内具潜在的致突变性。大鼠口服本药86.0 mg/kg/日(以mg/m2 计,约为人体剂量的10倍)或更高剂量,连续5天,引起睾丸不可逆萎缩。静脉给予大鼠本药5.11 mg/kg/日(以mg/m2 计,约为人体剂量的½),连续30天也可发生睾丸不可逆的萎缩。本药对人体具有潜在的致癌作用,但单用依托泊苷或合并应用其他抗癌药物的病人中,伴或不伴前期症状的急性白血病的报导罕见。发生白血病或白血病前期症候群的危险程度并不清楚。本药没有在实验室动物身上做过致癌试验。

对妊娠和哺乳的影响:
本药属妊娠D类,孕妇使用本药可能造成胚胎毒性,依托泊苷对小鼠及大鼠具有致畸胎性,因此很可能对人也有致畸性。在大鼠胚胎器官成形期,静脉给予依托泊苷0.4 mg/kg/日(以mg/m2计,相当于人体剂量的½0),能造成母体毒性、胚胎毒性以及致畸毒性(骨骼异常、露脑畸形和无眼畸形) ;更高的剂量1.2-3.6 mg/kg/日(以mg/m2 计,相当于人体剂量的1/7与½),造成90%~100%的胚胎吸收。在小鼠受孕后第6、第7、第8天,腹腔内单次给予1.0 mg/kg(以mg/m2计,相当于人体剂量的1/16)的依托泊苷引起胚胎毒性,头颅畸形以及大部分骨骼畸形。受孕后第7日,腹腔给予1.5 mg/kg(以mg/m2 计,相当于人体剂量的1/10),使宫内死胎率以及胚胎畸形上升,胚胎平均体重显著下降。应将本药对胚胎的潜在危险告之使用本品的孕妇,或用药期受孕妇女。育龄妇女应被告之避免怀孕。

哺乳期妇女:
现尚不明了本品是否由人乳汁排出。但是许多药物经乳汁排泄,且本药可使对哺乳婴儿发生严重副反应,因此,应权衡药物对母亲的重要性,慎重决定应停止哺乳或者停药。

对儿童的影响:
尚未明确儿童使用本品的安全性和有效性。

规格:
 100毫克/5毫升/瓶
剂 型: 针剂
生产厂家: 百时美施贵宝(中国)


ETOPOPHOS VIAL 100MG 1

Generic Name: ETOPOSIDE PHOSPHATE
Class: R
Manufacture: BRISTOL-MYERS SQUIBB USPG
中文名: 凡毕复
Strength: 100MG
Size: 1
Unit: EACH


标题:国家批准新药:注射用磷酸依托泊苷(凡毕复)
新药类别:进口
剂型:注射剂0.1g
规格:0.1g
批准文号:注册证号H20030113
厂家:百时美施贵宝(中国)投资有限公司(美国)

 

序号 通用名
商品名
剂型
规格
单位
质量层次
零售价(元)
生产企业
4252 依托泊苷软胶囊

拉司太特

软胶囊

0.025g

粒/盒
单独定价
921.6
日本化药株式会社
4253 依托泊苷软胶囊

泊瑞

软胶囊

0.05g

粒/盒
GMP
205.9
青岛海尔药业有限公司
4254 依托泊苷软胶囊

威克

软胶囊

0.05g

粒/盒
GMP
205.9
江苏恒瑞医药股份有限公司
4255 依托泊苷注射液

注射液

5ml:0.1g

瓶/支/盒
GMP
64.4
贵州汉方制药有限公司
4256 依托泊苷注射液

注射液

5ml:0.1g

瓶/支/盒
GMP
74.8
上海旭东海普药业有限公司
4257 依托泊苷注射液

注射液

5ml:0.1g

瓶/支/瓶
GMP
13.1
江苏恒瑞医药股份有限公司
4258 依托泊苷注射液

注射液

5ml:0.1g

瓶/支/支
GMP
13.5
山东鲁抗辰欣药业有限公司
4259 依托泊苷注射液

注射液

5ml:0.1g

瓶/支/支
GMP
14.9
齐鲁制药有限公司

Brand names: Etopophos®Toposar®VePesid®
Chemical formula:
Drug Forms:
Etoposide Oral capsule (below)
Etoposide Solution for injection
Etoposide Phosphate Solution for injection


Español:
Etopósido, Cápsula oral
Etopósido, Solución para inyección
Fosfato de Etopósido, Solución para inyección


Etoposide Oral capsule

What is this medicine?

ETOPOSIDE, VP-16 (e toe POE side) is a chemotherapy drug. It is used to treat small cell lung cancer and other cancers.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•infection
•kidney disease
•low blood counts, like low white cell, platelet, or red cell counts
•an unusual or allergic reaction to etoposide, other chemotherapeutic agents, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not open, crush, or chew the capsules. It is advisable to wear gloves when handling this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, this is not harmful. Use the gel the next chance you get. Do not use double doses or extra doses.


What may interact with this medicine?

•cyclosporine
•medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim
•vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
•signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
•signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
•signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
•breathing problems
•changes in vision
•mouth or throat sores or ulcers
•pain, tingling, numbness in the hands or feet
•redness, blistering, peeling or loosening of the skin, including inside the mouth
•seizures
•vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•change in taste
•diarrhea
•hair loss
•nausea
•stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

 

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

责任编辑:admin


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