Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Malta Medicines Authority
IRINOTECAN
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
L01CE02
IRINOTECAN 20 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
IRINOTECAN 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2010-05-07
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER CAMPTO® 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 CAMPTO is and what it is used for 2. What you need to know before you use CAMPTO 3. How to use CAMPTO 4. Possible side effects 5. How to store CAMPTO 6. Contents of the pack and other information 1. WHAT CAMPTO IS AND WHAT IT IS USED FOR CAMPTO 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. CAMPTO is indicated in combination with other medicines for the treatment of patients with advanced or metastatic cancer of the colon or rectum. CAMPTO 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 CAMPTO DO NOT USE CAMPTO: • 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 CAMPTO contains”) • if you are a breast-feeding woman (see section 2) • if your bilirubin level is higher than 3 times the upper limit of the 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’s Wort (a herbal extract containing Hypericum) • if you are to take or have Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CAMPTO 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 34.66 mg of irinotecan as 40 mg of irinotecan hydrochloride, trihydrate (40 mg/2 mL). One vial of 5 mL contains 86.65 mg of irinotecan as 100 mg of irinotecan hydrochloride, trihydrate (100 mg/5 mL). One vial of 15 mL contains 259.95 mg of irinotecan as 300 mg of irinotecan hydrochloride, trihydrate (300 mg/15 mL). Excipient(s) with known effect Sorbitol CAMPTO 20 mg/mL concentrate for solution for infusion contains 90 mg of sorbitol (E420) in each 2 mL of solution, which is equivalent to 90 mg/2 mL. CAMPTO 20 mg/mL concentrate for solution for infusion contains 225 mg of sorbitol (E420) in each 5 mL of solution, which is equivalent to 225 mg/5 mL. CAMPTO 20 mg/mL concentrate for solution for infusion contains 675 mg of sorbitol (E420) in each 15 mL of solution, which is equivalent to 675 mg/15 mL For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATION 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 RAS wild-type metastatic colorectal cancer, who had not Page 2 of 25 received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy (see section 5.1). CAMPTO in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patie Կարդացեք ամբողջական փաստաթուղթը