Posology : מינונים

4.2      Posology and method of administration

Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision.

Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.

Simulect is to be         used    concomitantly     with   ciclosporin   and   corticosteroid-based immunosuppression.
Posology

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. The second 20 mg dose should be given 4 days after transplantation. The second dose should be 

SIM API Sep23 V4                                                               REF EU SmPC Sep23 withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).

Children and adolescents (1-17 years)
In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. In paediatric 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. The second dose should be given 4 days after transplantation. The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).

Elderly (≥ 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.

Method of administration
Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.