CELLCEPT FOR I.V. INFUSION 500 mg/vial

INJECTION, POWDER, FOR SOLUTION

**2.2. Dosage and Administration** Please refer to full prescribing information for corticosteroids and either ciclosporin or tacrolimus, which are used in combination with CellCept. _Standard Dosage for prophylaxis of renal rejection_ A dose of 1 g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. Although a dose of 1.5g administered twice daily (daily dose of 3g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2g per day of CellCept demonstrated an overall better safety profile compared to patients receiving 3g per day of CellCept. _Standard Dosage for prophylaxis of cardiac rejection_ A dose of 1.5g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3g) is recommended for use in cardiac transplant patients. _Standard Dosage for prophylaxis of hepatic rejection_ A dose of 1.0g administered intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2g) or 1.5g orally twice a day (daily dose of 3g) is recommended for use in hepatic transplant patients. For Oral Administration only: _Standard dosage for treatment of refractory renal rejection_ A dose of 1.5 g administered twice a day (daily dose of 3g) is recommended for management of refractory rejection. _Oral administration (see 3.2.1 Pharmacokinetic Properties, Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_ The initial dose of CellCept should be given as soon as possible following renal, cardiac or hepatic transplantation. _Intravenous administration_ **Caution: CellCept i.v. solution must not be administered by rapid or bolus intravenous injection.** CellCept i.v. is an alternative dosage form to CellCept capsules and tablets recommended for patients unable to take oral CellCept. CellCept i.v. should be administered within 24 hours following transplantation. CellCept i.v. can be administered for up to 14 days. Patients should be switched to oral CellCept as soon as they can tolerate oral medication. Following reconstitution and dilution with 5% Dextrose intravenous infusion to a concentration of 6 mg/mL, CellCept i.v. must be administered by slow intravenous infusion over a period of NO LESS THAN 2 HOURS by either a peripheral or a central vein. **2.2.1. Special dosage instructions** Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 103/microlitre), dosing with CellCept should be interrupted or the dose should be reduced and the patient carefully observed (see 2.4 Warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For dosage instructions in special population, please refer to sections 2.5.4 Geriatric Use, 2.5.5 Renal Impairment and 2.5.6 Hepatic Impairment. **2.5. Use in Special Populations** **2.5.4. Geriatric Use** The recommended oral doses of 1 g twice daily for renal transplant patients, 1.5 g twice daily for cardiac or hepatic transplant patients is appropriate for elderly patients (see 2.4 Warnings and Precautions, 2.6 Undesirable effects, and 3.2.5 Pharmacokinetics in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **2.5.5. Renal Impairment** _Patients with severe renal impairment_: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73m2), outside of the immediate post-transplant period or after treatment of acute of refractory rejection, doses greater than 1 g administered twice a day should be avoided. (see 2.4 Warnings and Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. _Patients with delayed renal graft function post-transplant:_ No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively. (See 3.2 Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **2.5.6. Hepatic Impairment** No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. (see 3.2 Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available for cardiac transplant patients with severe hepatic parenchymal disease.