Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Fluorouracil 50 mg/mL;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
5000 mg/100mL
Solution for injection
Active: Fluorouracil 50 mg/mL Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Prescription
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.
Package - Contents - Shelf Life: Vial, glass, 100 mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. do not refrigerate or freeze
2019-02-05
Fluorouracil Accord – version 4.0 1 FLUOROURACIL ACCORD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING GIVEN FLUOROURACIL ACCORD? Fluorouracil Accord contains the active ingredient Fluorouracil. Fluorouracil Accord belongs to a group of medicines known as antineoplastic or cytotoxic agents. 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. For more information, see Section 1. Why am I using Fluorouracil Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN FLUOROURACIL ACCORD? Do not use if you have ever had an allergic reaction to any medicine containing Fluorouracil or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I am given Fluorouracil Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Fluorouracil Accord and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN FLUOROURACIL ACCORD? Fluorouracil Accord will be given to you by a doctor or a nurse. More instructions can be found in Section 4. How will I be given Fluorouracil Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN FLUOROURACIL ACCORD? THINGS YOU SHOULD DO • Tell your doctor immediately if you have a fever or infection before, during or after being given Fluorouracil Accord. • If you become pregnant during or soon after being given Fluorouracil Accord, tell your doctor. • Tell the surgeon or anaesthetist that you are being given Fluorouracil Accord if you are going t Perskaitykite visą dokumentą
Page 1 of 13 NEW ZEALAND DATA SHEET FLUOROURACIL ACCORD (FLUOROURACIL) INJECTION 1 PRODUCT NAME Fluorouracil Accord 50 mg/mL injection solution 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 for use as an intravenous infusion or injection. 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 admin Perskaitykite visą dokumentą