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详细处方信息以本药内容附件PDF文件（20197813001018.pdf）的“原文Priscribing Information”为准
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部分中文吉西他滨溶液处方资料（仅供参考）

【英文名称】GEMCITABINE INJECTION

【适用证】

吉西他滨溶液适用于：

治疗局部晚期（不可切除的II期或III期）或转移性（IV期）胰腺腺癌患者，以达到临床疗效反应（临床改善的综合指标

将局部晚期或转移性非小细胞肺癌（NSCLC）患者作为单一药物或与顺铂联合治疗。

与顺铂联合治疗膀胱IV期（局部晚期或转移性）膀胱移行细胞癌（TCC）患者。

与紫杉醇联合治疗无法切除，局部复发或转移性乳腺癌的患者，这些患者具有良好的表现，并且在基于蒽环类药物的辅助化疗后复发。

吉西他滨注射液应仅在具有使用化学治疗剂和癌症患者管理经验的合格医疗保健专业人员的监督下使用。只有在有足够的诊断和治疗设施的情况下，才能对治疗和并发症进行适当的管理。

老年病学（> 65岁）

盐酸吉西他滨在65岁以上的患者中耐受性良好。虽然清除受年龄影响（参见行动和临床药理学），但没有证据表明需要进一步调整剂量，（除了已经在DOSAGE中推荐的那些） 65岁以上的患者需要和管理。

儿科（<17岁）

尚未确定儿童的安全性和有效性。

【用法用量】

剂量注意事项

吉西他滨注射液仅用于静脉注射。

吉西他滨注射液应由经验丰富的化疗药物管理专业人员进行。

每次剂量前应对患者进行粒细胞和血小板计数的监测。

应定期进行身体检查并检查肾功能和肝功能，以检测非血液学毒性。

剂量升级或减少应基于患者所经历的毒性程度。

治疗中止

可能发生与盐酸吉西他滨相关的急性呼吸急促。支气管扩张剂，皮质类固醇和/或氧气可产生症状缓解。一些实质性肺毒性报告与使用盐酸吉西他滨相关的药物性肺炎一致（见不良反应）。这种毒性的机制尚不清楚。怀疑患有药物性肺炎的患者应停药，不得再次接受该药物的质疑。

推荐剂量

剂量 - 胰腺癌 吉西他滨注射液应以1 000 mg / m2的剂量静脉输注，每周一次，每次30分钟，最多7周（或直到毒性需要减少或保持剂量），然后从治疗中休息一周。随后的周期应包括每4周一次输注，连续3周，每4周一次。

有关剂量调整指南，请参阅下面的剂量调整，胰腺癌，非小细胞肺癌的剂量修改和膀胱患者的TCC。

剂量 - 非小细胞肺癌

单药吉西他滨注射液应以1 000 mg / m2的剂量静脉输注30分钟，每周一次，连续3周，然后休息一周。这个4周的周期重复进行。

盐酸吉西他滨与顺铂联合给药，为期4周或3周。按照4周的时间表，吉西他滨注射液应在每个28天周期的第1,8和15天静脉注射1000 mg / m2，持续30分钟。在输注吉西他滨注射液后第1天，顺铂应以100mg / m 2静脉内给药。在3周的时间表中，吉西他滨注射液应在每个21天周期的第1天和第8天静脉内以1 250 mg / m 2 30分钟给药。在第1天输注吉西他滨注射液后，应静脉注射剂量为100 mg / m2的顺铂。参见顺铂处方和水合指南的处方信息。

有关剂量调整指南，请参阅下面的剂量调整，胰腺癌，非小细胞肺癌的剂量修改和膀胱患者的TCC。

【禁忌】

吉西他滨注射液禁用于对该药物过敏的患者或容器配方或组分中的任何成分。 有关完整列表，请参阅产品专论中的剂量形式，成分和包装。

【INDICATIONS AND CLINICAL USE】

Gemcitabine Injection is indicated for the:

 Treatment of patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas to achieve a Clinical Benefit Response (a composite measure of clinical improvement).

 Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) as either a single agent or in combination with cisplatin.

 Treatment of patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder in combination with cisplatin.

 Treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy.

Gemcitabine Injection should be used only under the supervision of a qualified healthcare professional who is experienced in the use of chemotherapeutic agents and in the management of patients with cancer. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.

Geriatrics (>65 years of age)

Gemcitabine hydrochloride has been well tolerated in patients over the age of 65. Although clearance is affected by age (see ACTION AND CLINICAL PHARMACOLOGY), there is no evidence that further dose adjustments, (i.e. other than those already recommended in the DOSAGE AND ADMINISTRATION) are necessary in patients over the age of 65.

Pediatrics (<17 years of age)

Safety and effectiveness in children have not been established.

【CONTRAINDICATIONS 】

Gemcitabine Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING in the Product Monograph.

【DOSAGE AND ADMINISTRATION】

Dosing Considerations

 Gemcitabine Injection is for intravenous use only.

 Gemcitabine Injection should be administered by healthcare professionals experienced in the administration of chemotherapeutic drugs.

 Patients should be monitored prior to each dose for granulocyte and platelet counts.

 Periodic physical examination and checks of renal and hepatic function should be made to detect non-hematologic toxicity.

 Dosage escalation or reduction should be based upon the degree of toxicities experienced by the patient.

Treatment Discontinuation

Acute shortness of breath in association with gemcitabine hydrochloride administration may occur. Bronchodilators, corticosteroids and/or oxygen produce symptomatic relief. Some reports of parenchymal lung toxicity were consistent with drug-induced pneumonitis in association with the use of gemcitabine hydrochloride (see ADVERSE REACTIONS). The mechanism of this toxicity is not known. Patients suspected of experiencing drug-induced pneumonitis should be discontinued and not be re-challenged with the drug.

Recommended Dose

Dosage – Pancreatic Cancer Gemcitabine Injection should be used by IV infusion at a dose of 1 000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by one week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

For dose adjustment guidelines, see Dosage Adjustment, Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer and TCC of the Bladder Patients below.

Dosage – Non-Small Cell Lung Cancer

Single-agent Gemcitabine Injection should be administered by IV infusion at a dose of 1 000 mg/m2 over 30 minutes once weekly for three consecutive weeks, followed by a one-week rest period. This 4-week cycle is repeated.

Gemcitabine hydrochloride has been given in combination with cisplatin on either a 4-week or a 3-week schedule. With the 4-week schedule, Gemcitabine Injection should be administered intravenously at 1 000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine Injection. With the 3-week schedule, Gemcitabine Injection should be administered intravenously at 1 250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine Injection on Day 1. See cisplatin prescribing information for administration and hydration guidelines.

For dose adjustment guidelines, see Dosage Adjustment, Dose Modifications for Pancreatic Cancer, Non-Small Cell Lung Cancer and TCC of the Bladder Patients below.

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详细处方信息以本药内容附件PDF文件（20197813001018.pdf）的“原文Priscribing Information”为准
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