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GEMCITABINE HYDROCHLORIDE

ABINGEM

1g Lyophilized Powder for Injection

Indication*

(Intravenous) Metastatic Breast Cancer. Locally advanced Bladder Cancer, Metastatic Bladder Cancer, Locally advanced Ovarian Cancer, Metastatic Ovarian Cancer, Locally advanced Non-small Cell Lung Carcinoma, Metastatic Non-small Cell Lung Carcinoma, Locally advanced Adenocarcinoma of Pancreas, Metastatic Adenocarcinoma of Pancreas.

Directions for Use*

(Metastatic Breast Cancer) Adult: In patients with unresectable, locally recurrent cases who have relapsed following adjuvant/neoadjuvant chemotherapy: In combination with paclitaxel: 1,250 mg/m2 via infusion over 30 minutes on days 1 and 8 of a 21-days cycle. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. (locally advanced Bladder Cancer, Metastatic Bladder Cancer) Adult: In combination with cisplatin: 1,000 mg/m2 via infusion over 30 minutes on days 1 , 8, and 15 of each 28-day cycle, followed by a 1-week rest period. This 4-week cycle is hen repeated. Dose may be reduced with each cycle or within a cycle based on the amount of toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines). (locally advanced ovarian cancer, metastatic ovarian cancer) Adult: In cases that have relapsed at least 6 months after completion of platinum-based therapy: In combination with carboplatin:1,000 mg/m2 via infusion over 30 minutes on days 1 and 8 of each 21-day cycle. dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. (locally advanced non-small cell lung carcinoma, metastatic non-small cell lung carcinoma) Adult: As monotherapy: 1,000 mg/m2 once weekly via infusion over 30 minutes for 3 weeks followed by a 1-week rest period. This 4-week cycle is then repeated. In combination with cisplatin: 1,2250 mg/m2 via infusion over 30 minutes on days 1 and 8 each 21-day cycle, followed by a 1-week rest period. This 3-week cycle is then repeated. Alternatively, 1,000 mg/m2 via infusion over 30 minutes on days 1, 8, and 15 of each 28-day cycle, followed by a 1 week rest period. this 4-week cycle is then repeated. Dose may be reduced with each cycle or within a cycle based on toxicity. Patient should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. (locally advanced adenocarcinoma of pancreas, metastatic adenocarcinoma of pancreas) Adult: 1,000 mg/m2 once weekly via infusion over 30 minutes for 7 weeks, followed by a 1 week rest period. Subsequent cycles; 1,000 mg/m2 once weekly for 3 consecutive weeks out of every 4 weeks. Alternatively, 1,000 mg/m2 on days 1 ,8 25 of each 28-day cycle. Dose may be reduced with each cycle or within a cycle based on toxicity. Patients should have an absolute granulocyte count of at least 1,500 x 106/L and platelet count of 100,000 x 106/L prior to initiation of therapy. Treatment recommendations may vary among countries (refer to specific local guidelines).

Administration*

*written indications, directions, and administration are updated as of March 10, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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