Cisplatin

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Cisplatin Recall

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副作用和不良反应

顺铂注射会产生累积的肾毒性，并通过氨基糖苷抗生素增强。血清肌酐，血尿素氮（BUN），肌酐清除率以及镁，钠，钾和钙水平应在开始治疗前和随后的过程之前测量。在建议的剂量下，顺铂注射不应比每3至4周更频繁地给予一次（请参阅ADVERSE REACTIONS).Elderly patients may be more susceptible to nephrotoxicity (see预防措施：老年使用）。

有报道称，使用更高剂量的顺铂注射或比建议的剂量频率更高的患者中有严重的神经病。这些神经病可能是不可逆转的，被视为在托管果土分布，fexlexia以及本体感受和振动感觉的丧失中被视为异常。老年患者可能更容易受到周围神经病的影响（请参阅预防措施：老年使用）。

Loss of motor function has also been reported.

Anaphylactic-like reactions to Cisplatin injection have been reported. These reactions have occurred within minutes of administration to patients with prior exposure to Cisplatin injection, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.

Cisplatin injection can commonly cause ototoxicity which is cumulative and may be severe. Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (seeADVERSE REACTIONS).

硫嘌呤S-甲基转移酶（TPMT）基因中的某些遗传变异与服用常规剂量顺铂的儿童的耳毒性风险增加有关（见参见临床药理学）。Children who do not have one of these TPMT gene variants remain at risk for ototoxicity. All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose, of drug and for several years post therapy.

向孕妇施用顺铂注射会导致胎儿伤害。顺铂注射在细菌中是诱变的，并在组织培养的动物细胞中产生染色体像差。在小鼠中，顺铂注射具有致畸性和胚胎毒性。如果在怀孕期间使用该药物或服用该药物时患者怀孕，则应向患者了解对胎儿的潜在危害。应建议患者避免怀孕。

The carcinogenic effect of Cisplatin injection was studied in BD IX rats. Cisplatin injection was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 X 1 mg/kg body weight per week. Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies: 12 leukemias and 1 renal fibrosarcoma.

The development of acute leukemia coincident with the use of Cisplatin injection has been reported. In these reports, Cisplatin injection was generally given in combination with other leukemogenic agents.

Injection site reactions may occur during the administration of Cisplatin injection (seeADVERSE REACTIONS).Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.

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法律问题

There is currently no legal information available for this drug.

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FDA安全警报

目前，该药物没有FDA安全警报。

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制造商警告

目前还没有生产informa的警告tion available for this drug.

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FDA标记更改

There are currently no FDA labeling changes available for this drug.

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Uses

Cisplatin injection is indicated as therapy to be employed as follows:

Metastatic Testicular Tumors

在已经接受了适当的外科手术和/或放射治疗方法的转移性睾丸肿瘤患者中，与其他认可的化学治疗剂建立了联合疗法。

Metastatic Ovarian Tumors

In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin injection and cyclophosphamide. Cisplatin injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin injection therapy.

Advanced Bladder Cancer

Cisplatin injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.

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History

目前，该药物没有药物史。

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Other Information

Cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL or 100 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL or 100 mL, respectively. The pH range of Cisplatin Injection is 3.5 to 6.5.

Cisplatin injection infusion concentrate must be further diluted prior to administration (seeDOSAGE AND ADMINISTRATION: All Patients).

The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207° C.

来源

顺铂制造商

辉瑞实验室Div Pfizer Inc.

Cisplatin | Pfizer Laboratories Div Pfizer Inc.

Cisplatin injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.

Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin injection should not be used for preparation or administration. Aluminum reacts with cisplatin injection, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors
与其他认可的化学治疗剂结合治疗睾丸癌的通常顺铂注射剂量为每天20 mg/m2 IV，每周循环5天。
Metastatic Ovarian Tumors
The usual Cisplatin injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75–100 mg/m2 IV per cycle once every four weeks (DAY 1).

与顺铂注射结合使用时，环磷酰胺的剂量每4周（第1天）为600 mg/m2 IV。

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

在联合疗法中，顺铂注射和环磷酰胺被顺序施用。

作为单个药物，应为每四个周期一次以100 mg/m2 iv的剂量给予顺铂注射。
Advanced Bladder Cancer
Cisplatin injection should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients
Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6 to 8 hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin injection should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4,000/mm3). Subsequent doses of cisplatin injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

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Teva Parenteral Medicines, Inc.

Cisplatin | Teva Parenteral Medicines, Inc.

顺铂注射是通过缓慢静脉输注来给药的。顺铂注射不应通过快速静脉注射给予。

Note: Needles or intravenous sets containing aluminum parts that may come in contact with Cisplatin Injection should not be used for preparation or administration. Aluminum reacts with Cisplatin Injection, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors
与其他认可的化学治疗剂结合治疗睾丸癌的通常顺铂注射剂量为每天20 mg/m2 IV，每周循环5天。
Metastatic Ovarian Tumors
The usual Cisplatin Injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).

The dose of cyclophosphamide when used in combination with Cisplatin Injection is 600 mg/m2 IV once every 4 weeks (DAY 1).

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

In combination therapy, Cisplatin Injection and cyclophosphamide are administered sequentially.

作为单个药物，应为每四个周期一次以100 mg/m2 iv的剂量给予顺铂注射。
Advanced Bladder Cancer
Cisplatin Injection should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients
Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a Cisplatin Injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in ½ or ⅓ normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute Cisplatin Injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of Cisplatin Injection should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥ 100,000/mm3, WBC ≥ 4000/mm3). Subsequent doses of Cisplatin Injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

No Recall
Fresenius Kabi USA，LLC

Cisplatin | Fresenius Kabi Usa, Llc

顺铂通过缓慢的静脉输注来给药。不应通过快速静脉注射给出顺铂。

注意：包含可能与顺铂接触的铝部件的针或静脉内组不应用于制备或给药。铝与顺铂反应，导致沉淀形成和效力损失。

Metastatic Testicular Tumors

常规剂量顺铂治疗试验icular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.
Metastatic Ovarian Tumors

The usual cisplatin dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every 4 weeks (DAY 1).

与顺铂结合使用时，环磷酰胺的剂量为600 mg/m2 IV每4周（第1天）。

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

In combination therapy, cisplatin and cyclophosphamide are administered sequentially.

As a single agent, cisplatin should be administered at a dose of 100 mg/m2 IV per cycle once every 4 weeks.
Advanced Bladder Cancer

Cisplatin should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients

Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥ 100,000/mm3, WBC ≥ 4,000/mm3). Subsequent doses of cisplatin should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
静脉溶液的准备

准备预防措施

Caution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing cisplatin.

可能发生与意外暴露于顺铂有关的皮肤反应。建议使用手套。如果顺铂接触皮肤或粘膜，请立即并用肥皂和水彻底清洗皮肤，然后用水冲洗粘膜。以下参考文献中提供了更多信息。

Instructions for Preparation

The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

给药剂师注意：谨慎行事以防止无意间顺铂过量。如果每个周期大于100 mg/m2，请致电处方者。小瓶的铝和翻转印章已印在以下陈述中：

CALL DR. IF DOSE > 100 MG/M2/CYCLE.
稳定

Cisplatin is a sterile, multiple dose vial without preservatives.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Protect unopened container from light.

The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
Metastatic Testicular Tumors

常规剂量顺铂治疗试验icular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.
Metastatic Ovarian Tumors

The usual cisplatin dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every 4 weeks (DAY 1).

与顺铂结合使用时，环磷酰胺的剂量为600 mg/m2 IV每4周（第1天）。

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

In combination therapy, cisplatin and cyclophosphamide are administered sequentially.

As a single agent, cisplatin should be administered at a dose of 100 mg/m2 IV per cycle once every 4 weeks.
Advanced Bladder Cancer

Cisplatin should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients

Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥ 100,000/mm3, WBC ≥ 4,000/mm3). Subsequent doses of cisplatin should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
静脉溶液的准备

准备预防措施

Caution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing cisplatin.

可能发生与意外暴露于顺铂有关的皮肤反应。建议使用手套。如果顺铂接触皮肤或粘膜，请立即并用肥皂和水彻底清洗皮肤，然后用水冲洗粘膜。以下参考文献中提供了更多信息。

Instructions for Preparation

The aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

给药剂师注意：谨慎行事以防止无意间顺铂过量。如果每个周期大于100 mg/m2，请致电处方者。小瓶的铝和翻转印章已印在以下陈述中：

CALL DR. IF DOSE > 100 MG/M2/CYCLE.
稳定

Cisplatin is a sterile, multiple dose vial without preservatives.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Protect unopened container from light.

The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.

No Recall
迈兰机构有限责任公司

Cisplatin | Mylan Institutional Llc

Cisplatin injection is administered by slow intravenous infusion. CISPLATIN INJECTION SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.

Note: Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin injection should not be used for preparation or administration. Aluminum reacts with cisplatin injection, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors
与其他认可的化学治疗剂结合治疗睾丸癌的通常顺铂注射剂量为每天20 mg/m2 IV，每周循环5天。
Metastatic Ovarian Tumors
The usual Cisplatin injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75–100 mg/m2 IV per cycle once every four weeks (DAY 1).

与顺铂注射结合使用时，环磷酰胺的剂量每4周（第1天）为600 mg/m2 IV。

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

在联合疗法中，顺铂注射和环磷酰胺被顺序施用。

作为单个药物，应为每四个周期一次以100 mg/m2 iv的剂量给予顺铂注射。
Advanced Bladder Cancer
Cisplatin injection should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients
Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6 to 8 hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute cisplatin injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of cisplatin injection should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4,000/mm3). Subsequent doses of cisplatin injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

No Recall
Wg Critical Care, Llc

Cisplatin | Wg Critical Care, Llc

顺铂注射是通过缓慢静脉输注来给药的。顺铂注射不应通过快速静脉注射给予。

Note: Needles or intravenous sets containing aluminum parts that may come in contact with Cisplatin Injection should not be used for preparation or administration. Aluminum reacts with Cisplatin Injection, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors
与其他认可的化学治疗剂结合治疗睾丸癌的通常顺铂注射剂量为每天20 mg/m2 IV，每周循环5天。
Metastatic Ovarian Tumors
The usual Cisplatin Injection dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).

The dose of cyclophosphamide when used in combination with Cisplatin Injection is 600 mg/m2 IV once every 4 weeks (DAY 1).

For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.

In combination therapy, Cisplatin Injection and cyclophosphamide are administered sequentially.

作为单个药物，应为每四个周期一次以100 mg/m2 iv的剂量给予顺铂注射。
Advanced Bladder Cancer
Cisplatin Injection should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.
All Patients
Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a Cisplatin Injection dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute Cisplatin Injection in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.

A repeat course of Cisplatin Injection should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4000/mm3). Subsequent doses of Cisplatin Injection should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

No Recall