Posology : מינונים

4.2 Posology and method of administration

Posology
The posology depends on the indication, the administration regimen and the possible combination with other immunosuppressive agents.
The following dosage recommendations may be used as reference. Treatment can be discontinued without gradual tapering of the dose.

Immunosuppression in transplantation

Prophylaxis of acute graft rejection:
1 to 1.5 mg/kg/day for 2 to 9 days after transplantation of a kidney, pancreas or liver and for 2 to 5 after heart transplantation, corresponding to a cumulative dose of 2 to 7.5 mg/kg in heart transplantation and 2 to 13.5 mg/kg for other organs.


Treatment of acute graft rejection:
1.5 mg/kg/day for 3 to 14 days, corresponding to a cumulative dose of 4.5 to 21 mg/kg.
Treatment of acute graft versus host disease
The dosage must be defined depending on individual basis. It is usually between 2 and 5 mg/kg/day for 5 days.

Treatment of aplastic anaemia
2.5 to 3.5 mg/kg/day for 5 consecutive days, corresponding to a cumulative dose of 12.5 to
17.5mg/kg.
The indication for aplastic anaemia has not been established by controlled trials carried out with this medicinal product.

Method of administration
Thymoglobuline is usually administered within the context of a therapeutic regimen combining several immunosuppressive agents.

It is recommended to administer pre-medication with intravenous corticosteroids and antihistamines prior to infusion of rabbit anti-human thymocyte globulin. Anti-pyretic agents (e.g. paracetamol) may also increase the tolerability of the initial infusion.

Rabbit anti-human thymocyte globulin is infused after dilution in isotonic 0.9% sodium chloride or 5% glucose solution. Inspect solution for particulate matter after reconstitution. To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 μm in-line filter.

Infuse slowly into a high-flow vein. Adjust the infusion rate so that the total duration of infusion is not less than 6 hours. See section 4.4 and section 4.8 for advice about the management of any adverse events associated with infusion.