Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
fluorouracil, Quantity: 50 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide
Intravenous
1 x 2.5g/50mL vial
(S4) Prescription Only Medicine
Fluorouracil is indicated 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: Clear, colourless to slightly yellow solution, free from visible particulates.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store between 8-25 degrees celsius
Licence status A
2000-08-30
DBL™ FLUOROURACIL INJECTION BP D B L ™ F l u o r o u r a c i l I n j e c t i o n B P 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, nurse or pharmacist. 1. WHY AM I BEING TREATED DBL FLUOROURACIL INJECTION BP? DBL Fluorouracil Injection BP contains the active ingredient fluorouracil. DBL Fluorouracil Injection BP is used to treat some types of cancer. For more information, see Section 1. Why am I using DBL Fluorouracil Injection BP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL FLUOROURACIL INJECTION BP? Do not use if you have ever had an allergic reaction to fluorouracil or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, have an infection or high temperature, take any other medicines, or if you are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use DBL Fluorouracil Injection BP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Fluorouracil Injection BP 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 IS DBL FLUOROURACIL INJECTION BP GIVEN? Your doctor will decide what dose you will receive. This depends on your medical condition and other factors. Fluorouracil must only be given by a doctor or nurse. More instructions can be found in Section 4. How do I use DBL Fluorouracil Injection BP? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING TREATED WITH DBL FLUOROURACIL INJECTION BP? There are many important things to consider while you are taking this medicine. The most common and serious considerations are summarised below (see the full CMI for more details). THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using DBL Fluorouracil Injection BP. • Tell your doctor immediately Lugege kogu dokumenti
Version: pfpfluoi10522 Supersedes: Version pfpfluoi10821 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – DBL ™ FLUOROURACIL INJECTION BP (FLUOROURACIL) 1. NAME OF THE MEDICINE Fluorouracil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of DBL Fluorouracil Injection BP contains fluorouracil 25 mg or 50 mg. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL Fluorouracil Injection BP is a sterile, colourless, preservative-free solution containing 5- Fluorouracil in Water for Injections, prepared with the aid of sodium hydroxide. The pH of the solution is approximately 8.9. DBL Fluorouracil Injection BP is a clear, colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluorouracil is indicated 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 DOSE AND METHOD OF ADMINISTRATION DOSAGE The dosage being based on the patient's actual weight. Ideal weight is used only if the patient is obese or if there has been a spurious weight gain due to oedema, ascites or other forms of abnormal fluid retention. Prior to treatment each patient is to be carefully evaluated in order to estimate the optimum initial dosage of fluorouracil. THE TOTAL DAILY DOSE OF FLUOROURACIL SHOULD NOT EXCEED 1 GRAM. The following regimens have been recommended for use of fluorouracil as a single agent in adults: Version: pfpfluoi10522 Supersedes: Version pfpfluoi10821 Page 2 of 14 _INTRAVENOUS INFUSION _ 15 milligrams/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500 mL of 5% glucose given over a period of 4 hours. Infusion may be continued daily until the first gastrointestinal side effects occur, ie. stomatitis, diarrhoea, leuc Lugege kogu dokumenti