Manufacturer
Patheon Italia S.p.A(ITALY)
Registraction Number
MAL19990224ACRZ
Content:
Each vial contains:
Basiliximab: 20 mg
Excipients: Dibasic sodium phosphate (anhydrous), glycine, mannitol, monobasic potassium phosphate, sodium chloride, and sucrose.
Indications:
Prophylaxis of Acute Organ Rejection: Used in de novo allogeneic renal transplantation in adult and pediatric patients (1-17 years). It is used in combination with ciclosporin for microemulsion and corticosteroid-based immunosuppression.
Instructions:
Dosage:
-Adults: The standard total dose is 40 mg, given in two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The second dose should be given 4 days after transplantation.
-Children and Adolescents (1-17 years): For patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. For patients weighing 35 kg or more, the recommended dose is the adult dose.
Administration: Simulect should be administered under qualified medical supervision. It must be reconstituted with Sterile Water for Injection, USP, and administered intravenously.
Malaysia
