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: water for injections; mannitol; sulfuric acid; sodium hydroxide
Intravenous
5x1mg/1mL(E), 5x1mg/1mL, 1x1mg/1mL(E)
Not scheduled. Not considered by committee, (S4) Prescription Only Medicine
Vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. It is rarely possible to achieve equally good results with single agent treatment. Thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). See DOSAGE AND ADMINISTRATION for possible increased toxicity when used in combination therapy. It has been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, Wilm's tumour, osteogenic sarcoma, mycosis fungoides, Ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma
Visual Identification: A clear colourless solution free from particulate matter.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-10-08
DBL™ VINCRISTINE SULFATE INJECTION _Vincristine Sulfate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Vincristine Sulfate Injection. This medicine is also called vincristine. 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 or pharmacist has weighed the risks of you being given DBL Vincristine Sulfate Injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DBL VINCRISTINE SULFATE INJECTION IS USED FOR Vincristine belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear it referred to as chemotherapy. Vincristine is classified as a vinca alkaloid. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by vincristine, other effects may also occur (see Side Effects). Vincristine is used to treat certain cancers, including: • acute leukaemia • Hodgkin’s disease • non-Hodgkin’s disease • rhabdomyosarcoma • neuroblastoma • Wilm’s tumour • bone cancer • mycosis fungoides • Ewing’s sarcoma • uterine or cervical cancer • breast cancer • malignant melanoma • lung cancer • gynaecological childhood tumours Your doctor may have prescribed vincristine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Vincristine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL VINCRISTINE SULFATE INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN DBL VINCRISTINE SULFATE INJECTION IF YOU HAVE AN ALLERGY TO VINCRISTINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction Đọc toàn bộ tài liệu
Version: pfpvindi11121 Superscedes: hhpvindi10721 Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – DBL ™ VINCRISTINE SULFATE INJECTION (VINCRISTINE SULFATE) 1. NAME OF THE MEDICINE Vincristine sulfate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Vincristine Sulfate Injection: 1 mg/1 mL and 2 mg/2 mL injections contains vincristine sulfate 1 mg/mL and mannitol in Water for Injections. The solutions do not contain any preservative. Vincristine sulfate occurs as a white or slightly yellow, hygroscopic, amorphous or crystalline powder and is freely soluble in water and slightly soluble in alcohol. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL Vincristine Sulfate Injection is a clear colourless solution. The solutions do not contain any preservative. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vincristine sulfate is indicated in acute leukaemia. Current practices of cancer chemotherapy involve the simultaneous use of several agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. It is rarely possible to achieve equally good results with single agent treatment. Thus vincristine sulfate is often chosen as part of polychemotherapy because of lack of significant bone-marrow suppression (at recommended doses) and because of its unique clinical toxicity (neuropathy). See section 4.2 Dose and method of administration for possible increased toxicity when used in combination therapy. It has been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non-Hodgkin’s malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), 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 gynaecologi Đọc toàn bộ tài liệu