Active Ingredient: Mycophenolate mofetil
Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 grams mycophenolate mofetil, 2 times daily, over the duration of up to 14 days.
Mycophenolate mofetil 500 mg powder for concentrate for solution for infusion is an alternative dosage form to oral forms that may be administered for up to 14 days. The initial dose of mycophenolate mofetil 500 mg powder for concentrate for solution for infusion should be given within 24 hours following transplantation.
The recommended dose of mycophenolate mofetil for infusion in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Following reconstitution to a concentration of 6 mg/ml, mycophenolate mofetil 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein.
For:
Oral, 1 grams mycophenolate mofetil, 2 times daily.
Treatment should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
For:
Oral, 600 milligrams mycophenolate mofetil per square meter of body surface, 2 times daily.
The recommended mycophenolate mofetil initial dose for paediatric renal transplant patients is 600 mg/m² (of body surface area (BSA)), administered orally, twice daily (initial total daily dose not to exceed 2 g).
The recommended maintenance dose for paediatric renal transplant patients is 600 mg/m² twice daily (maximum total daily dose of 2 g).
As some adverse reactions occur with greater frequency in this age group compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
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