Երկիր: Նիդերլանդեր
Լեզու: հոլանդերեն
Աղբյուրը: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IRINOTECANHYDROCHLORIDE 3-WATER SAMENSTELLING overeenkomend met ; IRINOTECAN
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
L01XX19
IRINOTECANHYDROCHLORIDE 3-WATER COMPOSITION corresponding to ; IRINOTECAN
Concentraat voor oplossing voor infusie
MELKZUUR (D,L,+- VORM) (E 270) ; NATRIUMHYDROXIDE (E 524) ; SORBITOL (D-)(E 420) ; WATER VOOR INJECTIE,
Intraveneus gebruik
Irinotecan
Hulpstoffen: MELKZUUR (D,L,+- VORM) (E 270); NATRIUMHYDROXIDE (E 524); SORBITOL (D-)(E 420); WATER VOOR INJECTIE;
2009-10-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IRINOTECAN HCL-3-WATER CF 20 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Irinotecan HCl-3-water CF is and what it is used for 2. What you need to know before you use Irinotecan HCl-3-water CF 3. How to use Irinotecan HCl-3-water CF 4. Possible side effects 5. How to store Irinotecan HCl-3-water CF 6. Contents of the pack and other information 1. WHAT IRINOTECAN HCL-3-WATER CF IS AND WHAT IT IS USED FOR Irinotecan belongs to a group of medicines called cytostatics (anti-cancer medicines). Irinotecan 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. WHAT YOU NEED TO KNOW BEFORE YOU USE IRINOTECAN HCL-3-WATER CF DO NOT USE IRINOTECAN HCL-3-WATER CF IF YOU are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6), have any other bowel disease or a history of bowel obstruction, are breast feeding, have increased levels of bilirubin in the blood (more than 3 times the upper limit of normal), have severe bone marrow failure, have a poor general health (evaluated by an international standard), are using the natural remedy St John’s Wort (Hypericum perforatum). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using any medicine. This medicine is intended for adults only. Check wit Կարդացեք ամբողջական փաստաթուղթը
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irinotecan HCl-3-water CF 20 mg/ml concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg/ml irinotecan. Each vial with 2 ml concentrate contains 40 mg of irinotecan hydrochloride trihydrate. Each vial with 5 ml concentrate contains 100 mg of irinotecan hydrochloride trihydrate. Each vial with 15 ml concentrate contains 300 mg of irinotecan hydrochloride trihydrate. Each vial with 25 ml concentrate contains 500 mg of irinotecan hydrochloride trihydrate. Excipients with known effect: Sorbitol E420 Vials with 2 ml concentrate contain 90 mg of sorbitol. Vials with 5 ml concentrate contain 225 mg of sorbitol. Vials with 15 ml concentrate contain 675 mg of sorbitol. Vials with 25 ml concentrate contain 1125 mg of sorbitol. Sodium hydroxide E 524 Vials with 2 ml concentrate contain 0.4 mg of sodium hydroxide. Vials with 5 ml concentrate contain 1.0 mg of sodium hydroxide. Vials with 15 ml concentrate contain 3 mg of sodium hydroxide. Vials with 25 ml concentrate contain 5 mg of sodium hydroxide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear colourless to pale yellow solution. pH 3.2 – 3.8 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irinotecan HCl-3-water CF 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 b Կարդացեք ամբողջական փաստաթուղթը