Country: Malta
Language: English
Source: Medicines Authority
IRINOTECAN
Fresenius Kabi Oncology PLC
L01XX19
IRINOTECAN
CONCENTRATE FOR SOLUTION FOR INFUSION
IRINOTECAN 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2012-03-07
PACKAGE LEAFLET: INFORMATION FOR THE USER IRINOTECAN KABI 20 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION Irinotecan hydrochloride trihydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Irinotecan Kabi is and what it is used for 2. What you need to know before you use Irinotecan Kabi 3. How to use Irinotecan Kabi 4. Possible side effects 5. How to store Irinotecan Kabi 6. Contents of the pack and other information 1. WHAT IRINOTECAN KABI IS AND WHAT IT IS USED FOR Irinotecan Kabi belongs to a group of medicines called cytostatics (anti-cancer medicines). This medicine is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines (i.e. 5-fluorouracil/folinic acid, bevacizumab, cetuximab, capecitabine) or alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN KABI DO NOT USE IRINOTECAN KABI - if you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6). - if you have any other bowel disease or a history of bowel obstruction - if you are breast-feeding - if you have increased levels of bilirubin in the blood (more than 3 times the upper limit of normal) - if you do not have enough blood cells(severe bone marrow failure) - if you are in a poor general health (evaluated by an international standard) - if you are using the natural remedy St Johns’ Wort (_Hypericum perforatum_). Please consult the package leaflet of cetuximab, bevacizumab or capecitabine for additional informati Read the complete document
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irinotecan Kabi 20 mg/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). One vial of 2 ml contains 40 mg of irinotecan hydrochloride trihydrate. One vial of 5ml contains 100 mg of irinotecan hydrochloride trihydrate. One vial of 15 ml contains 300 mg of irinotecan hydrochloride trihydrate. One vial of 25 ml contains 500 mg of irinotecan hydrochloride trihydrate. Excipient(s) with known effect: 45 mg sorbitol (E420) per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The concentrate is a light yellow coloured solution, free from visible particles. pH: 3.0 to 3.8 Osmolarity: 250 to 400 mOsm/kg . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irinotecan Kabi 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 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). Irinotecan in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma. Irinotecan in combination with 5-fluorouracil, folinic acid and bevacizumab is Page 2 of 24 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. After dilution Irinotecan Kabi, solution for infu Read the complete document