Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL
Wockhardt Bio Pty Ltd
irinotecan hydrochloride trihydrate
Injection, concentrated
Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid; lactic acid; sorbitol
Intravenous
1 Vial per pack
(S4) Prescription Only Medicine
Irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.
Visual Identification: Clear yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-10-13
IRINOTECAN 1 v1.1 IRINOTECAN WKT _Irinotecan hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about IRINOTECAN WKT. 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 IRINOTECAN WKT 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 IRINOTECAN WKT IS USED FOR IRINOTECAN WKT 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. IRINOTECAN WKT may be used once spread of cancer beyond the bowel is first diagnosed. At this time IRINOTECAN WKT will be given in combination with other anticancer medicines. Alternatively, IRINOTECAN WKT 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 IRINOTECAN WKT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. _USE IN CHILDREN_ It is not known if IRINOTECAN WKT is safe and effective in the treatment of children. BEFORE BEING TREATED WITH IRINOTECAN WKT _WHEN IRINOTECAN WKT _ _MUST NOT BE GIVEN_ IRINOTECAN WKT 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 _ _IRINOTECAN WKT_ You should be treated with IRINOTECAN WKT 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 Đọc toàn bộ tài liệu
Irinotecan WKT Concentrated Injection v4.4 1 AUSTRALIAN PRODUCT INFORMATION – IRINOTECAN WKT CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Irinotecan hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION IRINOTECAN WKT injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata. It is a pale yellow to yellow crystalline powder that is slightly soluble in water and organic solvents. IRINOTECAN WKT injection is supplied as a sterile, clear yellow concentrated aqueous solution with pH 3.5. It is intended for dilution with 5% Glucose Injection or 0.9% Sodium Chloride Injection prior to infusion. In addition to irinotecan hydrochloride, the ingredients are sorbitol, lactic acid, sodium hydroxide and hydrochloric acid. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sterile concentrated solution for IV infusion 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy. 4.2 D OSE 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 Special Warnings and Precautions For Use) . C OMBINATION A GENT T HERAPY D OSAGE R EGIMENS _I_ _RINOTECAN INJECTION IN _ _C_ _OMBINATION WITH _ _5-F_ _LUOROURACIL _ _(5-_ _FU)_ _ AND _ _L_ _EUCOVORIN _ _(LV) _ Irinotecan injection should be administered as an intravenous infusion over 90 minutes (see Preparation of Infusion Solution). For all regimens, the dose of LV should be admi Đọc toàn bộ tài liệu