Country: Malta
Language: English
Source: Medicines Authority
IRINOTECAN HYDROCHLORIDE, TRIHYDRATE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
L01XX19
IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg
CONCENTRATE FOR SOLUTION FOR INFUSION
IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2012-03-07
Page 1 of 11 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. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 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 is an anticancer medicine containing the active substance irinotecan hydrochloride trihydrate Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body. Irinotecan is indicated in combination with other medicines for the treatment of patients with advanced or metastatic cancer of the colon or rectum. Irinotecan may be used alone in patients with metastatic cancer of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN KABI DO NOT USE IRINOTECAN KABI • if you have chronic inflammatory bowel disease and/or bowel obstruction • if you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6 “What Irinotecan contains”) • if you are a breast-feeding woman (see section 2) • if your bilirubin level is higher than 3 times the upper limit of normal range • if you have severe bone marrow failure • if you are in poor general condition (WHO performance status higher than 2) • if you are taking or have recently taken St John 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: Each ml contains 45 mg sorbitol (E420). 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, RAS 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 5-fluorouracil, folinic acid and bevacizumab is indicated for first- line treatment of patients with metastatic carcinoma of the colon or rectum. Irinotecan in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma. Page 2 of 24 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For adults only. Irinotecan Kabi solution for Read the complete document