Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
fluorouracil, Quantity: 5000 mg
Sandoz Pty Ltd
Fluorouracil
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections
Intravenous
1 vial pack
(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: Clear and colourless; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-03-24
Fluorouracil Ebewe® 1 FLUOROURACIL EBEWE® INJECTION 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 WITH FLUOROURACIL EBEWE INJECTION? Fluorouracil Ebewe Injection contains the active ingredient fluorouracil. Fluorouracil Ebewe Injection is used to treat some types of cancer. For more information, see Section 1. Why am I using Fluorouracil Ebewe Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FLUOROURACIL EBEWE INJECTION? 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, 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 use Fluorouracil Ebewe Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Fluorouracil Ebewe Injection 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 FLUOROURACIL EBEWE INJECTION 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 Fluorouracil Ebewe Injection? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FLUOROURACIL EBEWE INJECTION? 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). For more information, see Section 5. What should I know while using Fluorouracil Ebewe Injection? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Side effects of this medicine may include nausea; vomiting; diarrhoea; loss of appetite; hair or nail loss; changes in sk Preberite celoten dokument
210802-fluorouracil-ebewe-pi Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION FLUOROURACIL EBEWE ® (FLUOROURACIL) 1 NAME OF THE MEDICINE Fluorouracil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluorouracil Ebewe ® contains 50 mg/mL of fluorouracil. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Fluorouracil Ebewe 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 D OSE 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 G . The following regimens have been recommended for use of fluorouracil as a single agent in adults: _INTRAVENOUS INFUSION _ 15 mg/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500 mL of glucose 5% given over a period of four hours. Infusions may be continued daily until the first gastrointestinal side effects occur, i.e. stomatitis, diarrhoea, leucopenia, thrombocytopenia; treatment should then be discontinued. After the side effects have subsided and the WBC count has risen to 3,000 to 4,000/mm 3 or the platelet count to 80,000 to 100,000/mm 3 , the patient may then be placed on a maintenance therapy program. _INTRAVENOUS INJECTION _ 12 mg/kg bodyweight daily for three consecutive days. If toxic effects do not appear, the patient may then be given 6 mg/kg may be given intravenou Preberite celoten dokument