البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Pfizer Limited
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
40 mg/2ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CAMPTO 40 mg/2 ml, concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The concentrate contains 20 mg/ml irinotecan hydrochloride, trihydrate (equivalent to 17.33 mg/ml irinotecan). Vials of CAMPTO contain 40 mg or 100 mg of irinotecan hydrochloride, trihydrate. _For excipients, see “6.1 List of excipients”._ 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CAMPTO 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. CAMPTO in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy. CAMPTO in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults only. CAMPTO solution for infusion should be infused into a peripheral or central vein. RECOMMENDED DOSAGE: In monotherapy (for previously treated patient): The recommended dosage of CAMPTO is 350 mg/m² administered as an intravenous infusion over a 30- to 90- minute period every three weeks _(see « Instructions for Use/Handling » and « Special Warnings and Special Precautions for_ _Use » sections )._ In combination therapy (for previously untreated patient): Safety and efficacy of CAMPTO in combination with 5-fluorouraci اقرأ الوثيقة كاملة