البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Irinotecan hydrochloride trihydrate 20 mg/mL; ;
Pfizer New Zealand Limited
Irinotecan hydrochloride trihydrate 20 mg/mL
20 mg/mL
Solution for injection
Active: Irinotecan hydrochloride trihydrate 20 mg/mL Excipient: Hydrochloric acid Lactic acid Sodium hydroxide Sorbitol Water for injection
Vial, glass, 2 mL
Prescription
Prescription
Olon SpA
Package - Contents - Shelf Life: Vial, glass, - 2 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, glass, - 5 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 2 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 5 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 15 mL - 36 months from date of manufacture stored at or below 30°C protect from light
1996-08-30
CAMPTOSAR ® 1 CAMPTOSAR ® _Irinotecan hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CAMPTOSAR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of treating you with CAMPTOSAR against the expected benefits it will have for you. ASK YOUR DOCTOR IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE. KEEP THIS LEAFLET. You may need to read it again. WHAT CAMPTOSAR IS USED FOR CAMPTOSAR 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. One of the options in this situation is treatment with an anticancer medicine, known as chemotherapy. CAMPTOSAR may be used once spread of cancer beyond the bowel is first diagnosed. At this time CAMPTOSAR will be given in combination with other anticancer medicines. Alternatively, CAMPTOSAR is used alone when the cancer has not responded or has returned after initial treatment. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CAMPTOSAR HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. _USE IN CHILDREN _ It is not known if CAMPTOSAR is safe and effective in the treatment of children. BEFORE BEING TREATED WITH CAMPTOSAR _WHEN CAMPTOSAR MUST _ _NOT BE GIVEN _ CAMPTOSAR must not be given if you: are allergic to irinotecan hydrochloride or any of the ingredients listed at the end of this leaflet are or may become pregnant are breastfeeding or intend to breastfeed. _BEFORE TREATMENT WITH _ _CAMPTOSAR _ You should be treated with CAMPTOSAR by a doctor who is experienced in treating patients with cancer. Treatment will normally take place in a hospital because of the need for hospital facilities and skilled personnel. It is likely that your doctor will give you one or more medicines before administering CAMPTOSAR, to help stop you vomiting or feelin اقرأ الوثيقة كاملة
Version: pfdcampi11118 Supersedes: pfdcampi10914 Page 1 of 34 NEW ZEALAND DATA SHEET 1. PRODUCT NAME CAMPTOSAR® Injection: Irinotecan hydrochloride injection 20 mg/mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of CAMPTOSAR Injection contains 20 mg irinotecan hydrochloride. Excipient(s) with known effects: Sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. CAMPTOSAR 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 CAMPTOSAR is indicated for the first line treatment of patients with metastatic carcinoma of the colon or rectum, in combination with 5FU/leucovorin. CAMPTOSAR 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 (see section 4.4). Version: pfdcampi11118 Supersedes: pfdcampi10914 Page 2 of 34 COMBINATION AGENT THERAPY DOSAGE REGIMENS CAMPTOSAR injection in Combination with 5-Fluorouracil (5-FU) and Leucovorin (LV) CAMPTOSAR should be administered as an intravenous infusion over 90 minutes (see Preparation of Infusion Solution). For all regimens, the dose of LV should be administered immediately after CAMPTOSAR, with the administration of 5-FU to follow immediately after the administration of LV. The recommended regimens are shown in Table 1. TABLE 1: COMBINATION AGENT DOSAGE REGIMENS AND DOSE MODIFICATIONS A REGIMEN 1 6 week cycle. Treatment resumes Day 43 CAMPTOSAR LV 5-FU 125 mg/m 2 IV over 90 min on Day 1, 8, 15, 22, then 2 wk rest 20 mg/m 2 IV bolus injection Day 1, 8, 15, 22, then 2 wk rest 500mg اقرأ الوثيقة كاملة