国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
irinotecan hydrochloride trihydrate
Alphapharm Pty Ltd
irinotecan hydrochloride trihydrate
Registered
IRINOTECAN ALPHAPHARM _contains the active ingredient irinotecan hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE BEING TREATED WITH IRINOTECAN ALPHAPHARM. This leaflet answers some common questions about IRINOTECAN ALPHAPHARM. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking IRINOTECAN ALPHAPHARM against the benefits they expect it will have for you. ASK YOUR DOCTOR OR PHARMACIST, IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE. KEEP THIS LEAFLET. You may need to read it again. WHAT IRINOTECAN ALPHAPHARM IS USED FOR IRINOTECAN ALPHAPHARM contains the active ingredient, irinotecan hydrochloride. It is used to treat bowel cancer which has spread to other parts of the body. Cancer, which has spread, cannot be treated by surgery alone and one of the options in this situation is treatment with an anticancer medicine, known as chemotherapy. IRINOTECAN ALPHAPHARM may be used once spread of cancer beyond the bowel is first diagnosed. At this time IRINOTECAN ALPHAPHARM will be given in combination with other anticancer medicines. Alternatively, IRINOTECAN ALPHAPHARM is used alone when the cancer has not responded or has returned after initial treatment. Your doctor may have prescribed IRINOTECAN ALPHAPHARM for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IRINOTECAN ALPHAPHARM HAS BEEN PRESCRIBED FOR YOU. _USE IN CHILDREN_ It is not known if IRINOTECAN ALPHAPHARM is safe and effective in the treatment of children. BEFORE BEING TREATED WITH IRINOTECAN ALPHAPHARM Some information is provided below. However, always talk to your doctor if you have concerns or questions about your treatment. _WHEN IRINOTECAN MUST NOT_ _BE GIVEN_ IRINOTECAN must not be given if you: • are allergic to irinotecan hydrochloride, or any of the other ingredients listed at the end of this lea 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION IRINOTECAN ALPHAPHARM _Irinotecan hydrochloride concentrated injection _ _ _ _ _ 1 NAME OF THE MEDICINE Irinotecan hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Irinotecan Alphapharm contains 20mg irinotecan hydrochloride. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Concentrated injection. Irinotecan injection is supplied as a sterile, light yellow or pale yellow, clear, aqueous solution with pH 3.5. It is intended for dilution with 5% Glucose Injection or 0.9% Sodium Chloride Injection prior to infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irinotecan is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION It is recommended that patients receive premedication with antiemetic agents. Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms (refer to 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ). _Combination Agent Therapy _ _DOSAGE REGIMENS _ _ _ Irinotecan injection in Combination with fluorouracil (5-FU) and Leucovorin (LV) Irinotecan should be administered as an intravenous infusion over 90 minutes (refer to Preparation of Infusion Solution). For all regimens, the dose of LV should be administered immediately after Irinotecan, with the administration of 5-FU to follow immediately after the administration of LV. The recommended regimens are shown in Table 1. IRINOTECAN ALPHAPHARM – Product Information 2 TABLE 1: COMBINATION AGENT DOSAGE REGIMENS & DOSE MODIFICATIONS A REGIMEN 1 6 week cycle Treatment resumes Day 43 Irinotecan LV 5-FU 125mg/m 2 IV over 90 min on day 1, 8, 15, 22 then 2 wk rest 20mg/m 2 IV bolus injection day 1, 8, 15, 22 then 2 wk rest 500mg/m 2 IV bolus injection day 1, 8, 15 完全なドキュメントを読む