Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Malta Medicines Authority
IRINOTECAN HYDROCHLORIDE, TRIHYDRATE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
L01XX19
IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2019-06-12
PACKAGE LEAFLET: INFORMATION FOR THE USER IRINOTECAN MYLAN 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,nurse or pharmacist. _-_ 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 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 Mylan is and what it is used for 2. What you need to know before you use Irinotecan Mylan 3. How to use Irinotecan Mylan 4. Possible side effects 5. How to store Irinotecan Mylan 6. Contents of the pack and other information 1. WHAT IRINOTECAN MYLAN IS AND WHAT IT IS USED FOR Your medicine is called Irinotecan Mylan. Irinotecan Mylan belongs to a group of medicines called CYTOSTATICS (ANTI-CANCER MEDICINES). Irinotecan Mylan may be used alone or in combination with a number of other medicines used to treat cancer. These combinations may be used to treat CANCER OF THE LARGE INTESTINE (COLON OR RECUM) where the disease is at an ADVANCED STAGE. Your doctor may use a combination of Irinotecan Mylan with 5-FLUROURACIL/FOLINIC ACID (5FU/FA) and BEVACIZUMAB to treat your CANCER OF THE LARGE INTESTINE (COLON OR RECUM). Your doctor may use a combination of Irinotecan Mylan with CAPECITABINE with or without BEVACIZUMAB to treat your CANCER OF THE COLON OR RECUM. Your doctor may use a combination of Irinotecan Mylan with CETUXIMAB to trate a particular type of CANCER OF THE LARGE INTESTINE (KRAS WILD-TYPE) which expresses a protein called EGFR. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN MYLAN _ _ DO NOT USE IRINOTECAN MYLAN _-_ if you are allergic to IRINOTECAN HYDROCHLORIDE or any of the other Կարդացեք ամբողջական փաստաթուղթը
1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irinotecan Mylan 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 vial of 2ml contains 40 mg of irinotecan hydrochloride trihydrate. Each vial of 5ml contains 100 mg of irinotecan hydrochloride trihydrate. Each vial of 15ml contains 300 mg of irinotecan hydrochloride trihydrate. Each vial of 25ml contains 500 mg of irinotecan hydrochloride trihydrate. Excipients with known effect: Also includes sorbitol (45 mg/ml) and sodium (less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Pale yellow color clear aqueous solution, free from visible particles. pH 3.0 to 3.8. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irinotecan 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 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults only. Irinotecan solution for infus Կարդացեք ամբողջական փաստաթուղթը