Posology : מינונים

4.2   Posology and method of administration


Posology
The recommended dose of palivizumab is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community.


The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15.


Where possible, the first dose should be administered prior to commencement of the RSV season. Subsequent doses should be administered monthly throughout the RSV season. The efficacy of palivizumab at doses other than 15 mg per kg or of dosing differently from monthly throughout the RSV season has not been established.


The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1). Data, although limited, are available on greater than 5 doses (see sections 4.8 and 5.1); therefore the benefit in terms of protection beyond 5 doses has not been established.


To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.


For children undergoing cardiac bypass, it is recommended that a 15 mg/kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels. Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).


Method of administration
Palivizumab is administered intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique.


Injection volumes over 1 ml should be given as a divided dose.

Synagis solution for injection is a ready to use formulation. For instructions on special handling requirements, see section 6.6.