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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗癌药物->治疗卵巢癌药物
处方药:处方药
包装规格: 5毫升/小瓶
计价单位:
   
生产厂家英文名:
Bristol-Myers Squibb Co., Ltd.
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/4291403A1088_1_11/
该药品相关信息网址2:
https://www.medicinenet.com/carboplatin-injection/article.htm
原产地英文商品名:
Paraplatin Injection 50 mg, 5mL/vial (Minimum order qty: 20)
原产地英文药品名:
Carboplatin
中文参考商品译名:
铂尔定注射液50毫克,5毫升/小瓶 (最低购买量:20)
中文参考药品译名:
卡波铂
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
ovarian cancer, small cell lung cancer, head and neck cancer, germ cell tumorrespiratory disease
英文适应病症2:
thyroid cancer, cervical cancer, bladder cancer and non-small cell lung cancer
临床试验期:
完成
中文适应病症参考翻译1:
主要用于卵巢癌、小细胞肺癌、头颈部癌、生殖细胞肿瘤
中文适应病症参考翻译2:
可用于甲状腺癌、宫颈癌、膀胱癌及非小细胞肺癌
药品信息:

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 详细处方信息以本药内容附件文件(201882322411940.pdf)的“原文Priscribing Information”为准
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部分中文比阿培南静脉滴注处方资料(仅供参考)

药品英文名

Carboplatin

药品别名

铂尔定、卡波铂、顺羧酸铂、碳铂、顺二氨环丁烷羧酸铂、顺二氨环丁铂、Carboplatine、Carboplatinum、CBDCA、JM-8、Paraplatin、Platinum

药物剂型

注射剂(粉):50mg,150mg 450mg。

药理作用

卡铂为第二代铂类抗肿瘤药,具细胞周期非特异性,作用与烷化剂类似。卡铂细胞杀伤作用可能是由于其与DNA产生链间和链内交联,导致DNA损伤,以至DNA的复制和转录受损。单用时,卡铂的剂量4倍于顺铂,且细胞中出现DNA交联作用较顺铂缓慢。

药动学

卡铂的分布与顺铂相似,在肝、肾、皮肤和肿瘤中浓度最高。但卡铂的血浆蛋白结合率很低,呈不可逆,结合后缓慢排出体外,半衰期γ相至少为5天。α相为1~2h,β相为2.6~5.9h。卡铂主要由肾排泄,当肌酐清除率为每分钟60ml时,24h内由肾脏清除71%,其中给药量的65%在头12h推出,6%在其次12h排出,仅有3%~5%在96h后排出。目前尚不清楚剩余药物是经胆汁还是经其他途径排出。24h尿中的铂都是有活性的卡铂,这说明仅有极少药物在体内发生代谢。肌酐清除率低的患者药物半衰期延长,因而剂量应相应调整。卡铂不经肾小管分泌,这可能是卡铂的肾毒性发生率较顺铂低的原因。

适应证

与顺铂相似。主要用于卵巢癌、小细胞肺癌、头颈部癌、生殖细胞肿瘤,也可用于甲状腺癌、宫颈癌、膀胱癌及非小细胞肺癌。

禁忌证

1.对顺铂或其他含铂化合物有过敏史者。 2.严重肾功能不全(肌酐清除率低于每分钟20ml)者。 3.孕妇及哺乳妇女。 4.老年患者。

注意事项

1.慎用:

(1)感染水痘、带状疱疹等病毒者;

(2)肾功能不全者;

(3)严重骨髓抑制者;

(4)出血性肿瘤患者。

2.药物对妊娠的影响:本药有致畸作用,为FDA妊娠分类D类药物。3.用药前后及用药时应当检查或监测:

(1)听力;

(2)神经功能;

(3)血尿素氮、肌酐清除率与血清肌酐;

(4)血细胞比容、血红蛋白测定、白细胞分类与血小板计数,用药期间至少每周检查1次白细胞与血小板;

(5)血清钙、镁、钾、钠含量。

4.由于本药注射剂配方中含有甘露醇,故不能耐受甘露醇的患者可能也不能耐受卡铂的注射剂。

5.虽然本药对肾功能的影响低于顺铂,但用过顺铂者仍应谨慎,并注意肾功能变化。

6.本药的骨髓毒性取决于剂量,并与药物的肾清除率成反比,患者肾功能受损时,毒性增加。

不良反应

1.骨髓抑制:为剂量限制性毒性。主要为血小板减少和白细胞降低。血小板最低点出现在用药后2~3周,第4周后恢复。白细胞最低点为2~4周,恢复较血小板慢,可延迟到6周左右。

2.消化道反应:常见但仅为轻度到中度,呕吐远较顺铂轻。

3.肾功能损害:很少引起肾功能损害,但与氨基苷类抗生素同时使用时能增加肾功能不全的发生率。用药期间应多饮水,使每天尿量在2000ml以上。

4.其他:肝功能损害(胆红素、转氨酶或碱性磷酸酶水平升高)、变态反应、口腔炎和“流感样”综合征。

用法用量

1.静脉用药:1次给药,300~400mg/m2,静脉注射或静脉滴注,儿童可提高到560mg/m2,4周重复1次;或50~70mg/m2(一般1次100mg),每天1次,连用5天,4周重复。近年来多主张根据AUC(血药浓度-时间曲线下面积)决定用药剂量。

2.腹腔内注射:300~400mg/m2,每4周1次。

药物相应作用

1.本药与环孢素合用,可增加免疫抑制作用,在出现耐药性的一些肿瘤病例中可合用。

2.本药与活疫苗(如轮状病毒疫苗)合用时,可增加感染的危险性。故接受本药治疗的患者禁止注射活疫苗。处于缓解期的白血病患者,化疗结束后至少间隔3个月才能注射活疫苗。

3.阿米卡星、庆大霉素、卡那霉素、奈替米星、链霉素、妥布霉素等氨基糖苷类抗生素与本药合用时耳毒性增加。

4.本药与苯妥英钠合用,可使苯妥英钠的胃肠道呼吸减少,作用降低。 临床研究

卡铂为第二代铂类抗肿瘤药,其生化特性与DDP相似,但消化道反应、肾毒性及耳毒性均较低,而骨髓抑制明显。它与DDP有不完全交叉耐药,即既往使用DDP无效的患者,改用卡铂仍可能取得疗效。国外Ⅱ期临床单药试验表明,对DDP有效的肿瘤使用卡铂同样有效。另一组资料(n>2000)采用DDP/卡铂单独或联合化疗治疗初期的卵巢癌患者,结果表明在存活期方面两者无明显差异。由于其非血液学毒性较DDP低,故更容易为患者所接受。由于作用机制与DDP相同,可代替DDP用于某些肿瘤的治疗。

English name of the drug

Carboplatin

Drug alias

Platindine, carbopol, cisplatin, platinum, cisplatin, cisplatin, carboplatine, carboplatinum, CBDCA, JM-8, Paraplatin, Platinum

Pharmaceutical dosage form

Injection (powder): 50 mg, 150 mg, 450 mg.

Pharmacological action

Carboplatin is a second-generation platinum antitumor drug with a non-specific cell cycle that acts similarly to an alkylating agent. The killing effect of carboplatin may be due to its interstrand and intrachain cross-linking with DNA, resulting in DNA damage and impaired DNA replication and transcription. When used alone, the dose of carboplatin was 4 times that of cisplatin, and DNA cross-linking in cells was slower than that of cisplatin.

Pharmacokinetics

Carboplatin has a similar distribution to cisplatin and has the highest concentration in liver, kidney, skin and tumor. However, the plasma protein binding rate of carboplatin is very low, irreversible, and slowly excreted after binding, and the half-life γ phase is at least 5 days. The α phase is 1 to 2 h, and the β phase is 2.6 to 5.9 h. Carboplatin is mainly excreted by the kidney. When the creatinine clearance rate is 60ml per minute, 71% is cleared by the kidney within 24 hours, of which 65% of the dose is introduced in the first 12h, and 6% is discharged in the second 12h, only 3%~5. % is discharged after 96h. It is unclear whether the remaining drugs are excreted via bile or by other means. Platinum in 24h urine is active carboplatin, indicating that only very few drugs are metabolized in the body. Patients with low creatinine clearance have a prolonged drug half-life and the dose should be adjusted accordingly. Carboplatin is not secreted by the renal tubules, which may be the reason why the incidence of carboplatin nephrotoxicity is lower than that of cisplatin.

Indications

Similar to cisplatin. Mainly used for ovarian cancer, small cell lung cancer, head and neck cancer, germ cell tumor, can also be used for thyroid cancer, cervical cancer, bladder cancer and non-small cell lung cancer.

Contraindications

1. Those who have a history of allergies to cisplatin or other platinum-containing compounds. 2. Severe renal insufficiency (creatinine clearance rate is less than 20ml per minute). 3. Pregnant women and lactating women. 4. Elderly patients.

Notes

1. Use with caution:

(1) Infected with chickenpox, herpes zoster, etc.;

(2) Renal dysfunction;

(3) severe myelosuppressed;

(4) Patients with hemorrhagic tumors.

2. The effect of drugs on pregnancy: This drug has teratogenic effects and is classified as Class D drug for FDA pregnancy. 3. Check or monitor before and after medication and medication:

(1) Hearing;

(2) Neurological function;

(3) Blood urea nitrogen, creatinine clearance and serum creatinine;

(4) Hematocrit, hemoglobin measurement, white blood cell classification and platelet count, white blood cells and platelets are checked at least once a week during treatment;

(5) Serum calcium, magnesium, potassium, and sodium contents.

4. Because the drug injection formulation contains mannitol, patients who cannot tolerate mannitol may not be able to tolerate carboplatin injections.

5. Although the effect of this drug on renal function is lower than that of cisplatin, those who have used cisplatin should be cautious and pay attention to changes in renal function.

6. The bone marrow toxicity of this drug depends on the dose and is inversely proportional to the renal clearance rate of the drug. When the patient's renal function is impaired, the toxicity increases.

Adverse reactions

1. Myelosuppression: dose limiting toxicity. Mainly for thrombocytopenia and leukopenia. The lowest point of platelet appeared 2 to 3 weeks after administration and recovered after the 4th week. The lowest point of white blood cells is 2 to 4 weeks, and the recovery is slower than platelets, which can be delayed to about 6 weeks.

2. Digestive tract reaction: common but only mild to moderate, vomiting is much lighter than cisplatin.

3. Renal dysfunction: rarely causes renal dysfunction, but can increase the incidence of renal insufficiency when used with aminoglycoside antibiotics. Drink more water during the medication, so that the daily urine volume is above 2000ml.

4. Other: liver function damage (increased levels of bilirubin, transaminases or alkaline phosphatase), allergy, stomatitis and "flu-like" syndrome.

Usage and Usage

1. Intravenous medication: 1 dose, 300 ~ 400mg / m2, intravenous or intravenous drip, children can be increased to 560mg / m2, repeated once every 4 weeks; or 50 ~ 70mg / m2 (usually 100 times once), Once a day, for 5 days, repeated for 4 weeks. In recent years, it has been advocated to determine the dose according to AUC (area under the blood concentration-time curve).

2. Intraperitoneal injection: 300 to 400 mg/m2 once every 4 weeks.

The corresponding effect of drugs

1. The combination of this drug and cyclosporine can increase the immunosuppressive effect and can be used in some cases of drug-resistant tumors.

2. When used in combination with a live vaccine (such as a rotavirus vaccine), the drug may increase the risk of infection. Therefore, patients receiving this drug are prohibited from injecting live vaccines. Patients with leukemia who are in remission have a live vaccine at least 3 months after the end of chemotherapy.

3. Aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, netilmicin, streptomycin, and tobramycin have increased ototoxicity when used in combination with this drug.

4. The combination of this drug and phenytoin can reduce the gastrointestinal tract respiration of phenytoin and reduce the effect. Clinical research

Carboplatin is a second-generation platinum antitumor drug with similar biochemical properties as DDP, but with lower digestive tract, nephrotoxicity and ototoxicity, and significant bone marrow suppression. It has incomplete cross-resistance with DDP, that is, patients who have previously used DDP are not effective, and switching to carboplatin may still achieve efficacy. Foreign phase II clinical monotherapy trials have shown that carboplatin, which is effective for DDP, is equally effective. Another group of data (n>2000) used DDP/carboplatin alone or in combination with chemotherapy to treat patients with early ovarian cancer. The results showed no significant difference in survival. Because its non-hematologic toxicity is lower than DDP, it is easier for patients to accept. Because the mechanism of action is the same as DDP, it can replace DDP for the treatment of certain tumors.

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 详细处方信息以本药内容附件文件(201882322411940.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-3-20
附件:
201882322424612.pdf    

201882322411940.pdf    

 
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