Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Fresenius Kabi Oncology Plc
L01XX19
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
20 Micromol
Solution for Infusion
Product subject to prescription which may not be renewed (A)
irinotecan
Marketed
2008-11-03
IRINOTECAN-PACK INSERT-(ACCORD)-UK+IE-BORDON-592X300 (RFI)- UKH1125001DC Font Size: 10 Pt Date: 01 August 2017 Version: 01 Final Packaging Site: Bordon Mfg. Site: Baddi-2 Font: Times New Roman Dimension: 592x300 mm Folding Size: 60x33 mm _(Outline of folding size for indication purpose only, _ _it should be removed before final printing.)_ Black \\fre-kp-fp01\PDD-Artworks\Europe\Irinotecan\Irinotecan-UKH1125001DC-Accord procedure\Accord-Bordon\UK+IRL\2017 JUL\Master\Irinotecan-Pack Insert-(Accord)-UK+IE-Bordon-592x300 (RFI).indd Form No.: SOP/PDD/014-02 Rev. 00 PACKAGE LEAFLET: INFORMATION FOR THE USER IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Irinotecan Hydrochloride Trihydrate Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Irinotecan Hydrochloride is and what it is used for 2. Before you use Irinotecan Hydrochloride 3. How to use Irinotecan Hydrochloride 4. Possible side effects 5. How to store Irinotecan Hydrochloride 6. Further information 1. WHAT IRINOTECAN HYDROCHLORIDE IS AND WHAT IT IS USED FOR Irinotecan Hydrochloride belongs to a group of medicines called cytostatics (anti-cancer medicines). Irinotecan Hydrochloride is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines or alone. 2. BEFORE YOU USE IRINOTECAN HYDROCHLORIDE DO NOT USE IRINOTECAN HYDROCHLORIDE IF YOU • are allergic (hypersensitive) to Irinotecan Hydrochloride Trihydrate or any of the other ingredients of Irinotecan • have or had chronic inflammatory bowel disease or bowel obstruction • are pregnant or breast fe Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 20 mg Irinotecan hydrochloride trihydrate equivalent to 17.33 mg irinotecan. Each 2 ml or 5 ml or 15ml or 25 ml vial of Irinotecan concentrate for solution for infusion contains 40 mg or 100 mg or 300mg or 500 mg of Irinotecan hydrochloride trihydrate respectively. Excipient: Sorbitol E420 Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A pale yellow clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irinotecan 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 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. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults only. After dilution Irinotecan concentrate for solution for infusion should be infused into a peripheral or central vein. RECOMMENDED DOSAGE: In monotherapy (for previously treated patient): The recommended dosage of Irinotecan Hydrochloride Trihydrate is 350 mg/m² administered as an intravenous infusion over a 30 to 90 minute period every three weeks (see below “Method of Administration” and section 4.4 and 6.6). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lire le document complet