Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1   Pharmacodynamic properties
Pharmacotherapeutic group: immune sera and immunoglobulins, immunoglobulins, normal human for extravascular administration.
ATC code: J06B A01

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against various infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donations.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.

Beriglobin provides passive transfer of hepatitis A antibodies.

The mechanism of action in indications other than replacement therapy and hepatitis A prophylaxis is not fully elucidated, but includes immunomodulatory effects.

Paediatric population
No differences were seen in the pharmacodynamics properties between adult and paediatric study patients.

Pharmacokinetic Properties

5.2   Pharmacokinetic properties

Following subcutaneous administration of Beriglobin P, peak serum levels are achieved after approximately 2 days.

In a clinical trial with Beriglobin P (n=52), the subjects achieved sustained trough levels (mean 9.3 g/l ) over a period of 27 weeks when receiving median weekly doses of approximately 0.1 g/kg.IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

Paediatric population
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients.