Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
vincristine sulfate, Quantity: 1 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: mannitol; water for injections; sodium hydroxide; sulfuric acid
Intravenous
5 x 5mL
(S4) Prescription Only Medicine
Vincristine is used primarily in the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. It has also been used as part of combination therapy in the treatment of Hodgkin's disease, non-Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, Wilm's tumour, osteogenic sarcoma, mycosis fungoides, Ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. Vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but not recommended as primary treatment for this disorder
Visual Identification: Clear and colourless solution.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1994-06-22
Version: pfpvinci10921 Supersedes: pfpvinci10321 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – VINCRISTINE SULFATE INJECTION 1. NAME OF THE MEDICINE Vincristine sulfate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vincristine Sulfate Injection contains 1 mg/mL of vincristine sulfate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Vincristine Sulfate Injection is a sterile, hypertonic, preservative-free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vincristine is used primarily in the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. It has also been used as part of combination therapy in the treatment of Hodgkin’s disease, non-Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, Wilm’s tumour, osteogenic sarcoma, mycosis fungoides, Ewing’s sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. Vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but is not recommended as primary treatment for this disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION This preparation is for intravenous use only and is usually administered at weekly intervals. It can be fatal if administered intrathecally (see sections 4.3 Contraindications and 4.4 Special warnings and precautions for use). Vincristine should not be given intramuscularly, subcutaneously or intrathecally. Intrathecal use of vincristine usually results in death. When dispensed, flexible plastic containers containing this product should be labelled: FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY ANY OTHER ROUTE. Version: pfpvinci10921 Supersedes: pfpvinci10321 Page 2 of 16 DOSAGE Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administrating the dose of vincristine since overdosage may have very serious or fatal outcome (see section 4.9 O Đọc toàn bộ tài liệu