国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
fluorouracil, Quantity: 50 mg/mL
Accord Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid
Intravenous Infusion, Intravenous
1 vial
(S4) Prescription Only Medicine
Alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas.,Fluorouracil should only be used when other proven measures have failed or are considered impractical.
Visual Identification: A clear, colourless to slightly pale yellow solution in a glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-08
Version 2.0 Page 1 of 4 FLUOROURACIL ACCORD _Fluorouracil Injection Solution 250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 2.5 g/50 mL _ _and 5 g/100 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fluorouracil Accord. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLUOROURACIL ACCORD IS USED FOR Fluorouracil Accord belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear of these being called chemotherapy medicines. It is used to treat some types of cancer. Fluorouracil Accord is classified as an 'antimetabolite' type of cytotoxic agent. It works by interfering with the growth of cancer cells which are eventually destroyed. Your doctor, however, may prescribe Fluorouracil Accord for another purpose. ASK YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY FLUOROURACIL ACCORD HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Fluorouracil Accord is not addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT RECEIVE FLUOROURACIL ACCORD IF YOU HAVE AN ALLERGY TO FLUOROURACIL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction include: • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest; • swelling of the face, lips, tongue or other parts of the body; • rash, itching, hives or flushed, red skin; • dizziness or light-headedness. DO NOT RECEIVE FLUOROURACIL ACCORD IF YOU HAVE, OR HAVE HAD, ANY OF THE FOLLOWING MEDICAL CONDITIONS: • problems with blood clotting • an 阅读完整的文件
Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION FLUOROURACIL ACCORD (FLUOROURACIL) INJECTION 1 NAME OF THE MEDICINE Fluorouracil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluorouracil Accord injection solution contains fluorouracil as the active ingredient. Five strengths are available as follows: 250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 2.5 g/50 mL and 5 g/100 mL. The 2.5 g/50 mL and 5 g/100 mL vials are Pharmacy Bulk Packs. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Fluorouracil Accord Solution for Injection is a clear, colourless to slightly pale yellow solution containing fluorouracil. The pH of the fluorouracil injection solution is approximately 8.9. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. Fluorouracil should only be used when other proven measures have failed or are considered impractical. 4.2 D OSE AND METHOD OF ADMINISTRATION GENERAL DIRECTIONS Fluorouracil Accord contains no antimicrobial agent. The product is for single use in one patient only. Discard any residue. The use of the Pharmacy Bulk Pack should be restricted to suitably qualified pharmacists operating in suitably equipped hospital pharmacies or compounding centres. The Pharmacy Bulk Pack is intended for multiple dispensing but should be spiked only once. To reduce microbiological hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2°C to 8°C for not more than 24 hours after preparation. Administration should be completed within 24 hours of preparation of the infusion and any residue discarded according to the guidelines for the disposal of cytotoxic drugs (see HANDLING PRECAUTIONS AND SPILLS AND DISPOSAL ). Fluorouracil Injection may be administered by intravenous infusion or intravenous injection, the dosag 阅读完整的文件