Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1   Pharmacodynamic properties
Pharmacotherapeutic group: ATC code: J07B G01

Mechanism of action
Rabipur induces stimulation of lymphocytes and antibody-secreting plasmocytes resulting in production of RVNAs.

Clinical efficacy and safety
Pre-exposure prophylaxis
In clinical trials with previously unimmunised subjects almost all subjects achieve an adequate immune response (RVNAs ≥ 0.5 IU/ml) 3 to 4 weeks after the end of a primary series of three injections of Rabipur when given according to the recommended schedule by the intramuscular route.
Persistence of adequate immune response (RVNAs ≥ 0.5 IU/ml) for up to 2 years after primary immunization with Rabipur without booster doses has been found in clinical studies. As antibody concentrations slowly decrease, booster doses may be required to maintain antibody levels above 0.5 IU/ml.
The timing of booster doses after primary vaccination with rapid regimen or after concomitant vaccination has not yet been established. Due to a faster decline in immune response compared with the conventional schedule a shorter interval between primary vaccination and booster administration may be needed compared with the conventional vaccine schedule. (see section 4.2).
In a clinical trial, a booster dose of Rabipur administered 1 year after primary immunisation elicited a 10-fold or higher increase in Geometric Mean Concentrations (GMCs) by day 30. It has also been demonstrated that individuals who had previously been immunised with Human Diploid Cell Vaccine (HDCV) developed a rapid anamnestic response when boosted with Rabipur.
Post-exposure prophylaxis
In clinical studies Rabipur elicited adequate neutralising antibodies (≥ 0.5 IU/ml) in almost all subjects by day 14 or 30, when administered according to the 5- dose (day 0, 3, 7, 14, 28; 1.0 ml each, intramuscular) Essen regimen or 4-dose (day 0 [2 doses], 7, 21; 1.0 ml each, intramuscular) Zagreb regimen.
Concomitant administration of Human Rabies Immunoglobulin with the first dose of rabies vaccine caused a slight decrease in GMCs (Essen regimen). However, this was not considered to be clinically relevant.


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Pharmacokinetic Properties

5.2   Pharmacokinetic properties
Not applicable