ransplantation patients. Disposition parameters were not influenced to a clinically relevant extent by age (1–11 years), body weight (9–37 kg) or body surface area (0.44–1.20 m2) in this age group. In adolescents (age 12–16 years, n=14), the steady-state distribution volume was 7.8±5.1 l, half-life was 9.1±3.9 days and clearance was 31±19 ml/h. Disposition in adolescents was similar to that in adult renal transplantation patients. The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients.
5.3 Preclinical safety data
No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly for 39 weeks followed by a 13-week withdrawal period. In the 39-week study, the highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients given the recommended clinical dose together with concomitant immunosuppressive therapy.
No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis period.
No mutagenic potential was observed in vitro.
6. Pharmaceutical particulars
6.1 List of excipients
Powder
Potassium dihydrogen phosphate
Disodium phosphate, anhydrous
Sodium chloride
Sucrose
Mannitol (E421)
Glycine
Solvent
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Powder: 3 years
Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).
6.4 Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
6.5 Nature and contents of container
Simulect powder
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Solvent
Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Simulect is also available in vials with 10 mg basiliximab.
6.6 Special precautions for disposal and other handling
Simulect 10 mg powder and solvent for solution for injection or infusion
Reconstitution
To prepare the solution for infusion or injection, take 2.5 ml of water for injections out of the accompanying 5 ml-ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder. Shake the vial gently to dissolve the
