Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 500 mg
Accord Healthcare Pty Ltd
Injection, powder for
Excipient Ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; citric acid; polysorbate 80
Intravenous
1, 4
(S4) Prescription Only Medicine
Tradename] is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.,[Tradename] is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.
Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-05-18
Mycophenolate Accord - version 2 1 MYCOPHENOLATE 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 USING MYCOPHENOLATE ACCORD? Mycophenolate Accord contains the active ingredient mycophenolate mofetil. Mycophenolate Accord is used to prevent the rejection of a transplanted organ and work by stopping your immune system from reacting to the transplanted organ. There are many different types of medicines used to prevent rejection of a transplanted organ. Mycophenolate Accord may be used together with other medicines known as ciclosporin and corticosteroids. For more information, see Section 1. Why am I using Mycophenolate Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MYCOPHENOLATE ACCORD? Do not use if you have ever had an allergic reaction to mycophenolate mofetil, polysorbate 80 or any of the other 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 Mycophenolate Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Mycophenolate 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 DO I USE MYCOPHENOLATE ACCORD? Mycophenolate Accord is an injection for infusion and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Mycophenolate Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MYCOPHENOLATE ACCORD? THINGS YOU SHOULD DO • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Mycophenolate Accord. • Remind any doctor, dentist or pharmacist you visit that you are using Mycophenolate Accord. • If you are going t Прочитайте повний документ
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION MYCOPHENOLATE ACCORD (MYCOPHENOLATE MOFETIL) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Mycophenolate mofetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 500 mg of mycophenolate mofetil. For the full list of excipients, see SECTION 6.1. LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Mycophenolate Accord is a white to off white powder for injection. Mycophenolate Accord must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient. Reconstitution and dilution with 5% glucose intravenous infusion as recommended yields a clear colourless solution of mycophenolate mofetil, 6 mg/mL. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Mycophenolate Accord is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Mycophenolate Accord is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _Mycophenolate mofetil oral formulations are unavailable in this brand however, are available in other _ _brands. Where correct dosing requires mycophenolate mofetil tablet, capsule or oral suspension, refer _ _to the specific product information for these formulations for their complete dosage and administration _ _instructions. _ The initial dose of Mycophenolate Accord should be given as soon as clinically feasible following transplantation. Intravenous administration is recommended in those patients unable to take oral medication. However, oral administration should be initiated as soon as possible. Adults _Renal Transplantation _ The recommended dose in renal transplant patients is 1 g administered orally or intravenously twice daily (2 g daily dose). _Cardiac Transplantation _ The recommended dose in cardiac transplant patients is 1.5 g administered orally or intravenously twice daily (3 g daily dose). _Hepatic Transplantation _ The recommended dose in Прочитайте повний документ