Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Pfizer Limited
20 Mg/Ml
Concentrate for Soln for Inf
2004-10-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CAMPTO 20mg/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). 5 ml Vials of CAMPTO contain 100 mg of irinotecan hydrochloride, trihydrate. _For excipients, see ‘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, KRAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy _(please see 5.1)._ 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. Campto in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma. 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 350mg/m² administered as an intravenous infusion over a 30- to 90- minute period every three weeks Read the complete document