Description

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

Each vial of 5 ml contains 100 mg of irinotecan hydrochloride trihydrate (100 mg/5 ml)

Therapeutic indications:

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion is indicated for the treatment of patients with advanced colorectal cancer:
• In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease,
• As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild- type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy.