Simulect Dosage/Direction for Use

Dosage: General target population: Adults: The standard total dose is 40 mg, given in two doses of 20 mg each. The first 20 mg dose should be given within 2 hours prior to transplantation surgery. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. The second 20 mg dose should be given 4 days after transplantation. The second dose should be withheld if severe hypersensitivity reactions to Simulect or graft loss occur (see PRECAUTIONS).
Special populations: Pediatric patients (1-17 years): In pediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. The second dose should be given 4 days after transplantation. The second dose should be withheld if severe hypersensitivity reactions to Simulect or graft loss occur (see PRECAUTIONS).
Geriatric patients (≥ 65 years): There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Mode of administration: Reconstituted Simulect can be administered either as an intravenous infusion over 20-30 minutes or as a bolus injection.
For information on reconstituting Simulect, see INSTRUCTIONS FOR USE AND HANDLING as follows.
Instructions for Use and Handling: Simulect 20 mg: To prepare the infusion/injection solution, add 5 mL of water for injection from the accompanying ampoule aseptically to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder. Use the reconstituted, colourless, clear to opalescent solution as soon as possible, but it may be stored at 2 to 8°C for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 mL or greater with normal saline or dextrose 5% for infusion.
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/substances and should always be given through a separate infusion line.
Compatibility with the following infusion sets has been verified: Infusion bag: Baxter minibag NaCl 0.9%.
Infusion sets: Luer Lock, H. Noolens; Sterile vented i.v. set, Abbott; Infusion set, Codan; Infusomat, Braun; Infusionsgerät R 87 plus, Ohmeda; Lifecare 5000 Plumset Microdrip, Abbott; Vented basic set, Baxter; Flashball device, Baxter; Vented primary administration set, Imed.
Compatibility with other commercial devices has not been tested.