Human normal immunoglobulin G

Therapeutic indications

Human normal immunoglobulin G is indicated for:

Primary immunodeficiency syndromes with impaired antibody production, secondary immunodeficiencies (SID)

Population group: only minors (0 - 18 years old) , adults (18 - 65 years old)

Replacement therapy in adults, children and adolescents (0-18 years) in:

Primary immunodeficiency syndromes with impaired antibody production.
Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.

^* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

0.2-0.5 g/kg and thereafter a cumulative monthly dose of the order of 0.4-0.8 g/kg body weight

Immunomodulatory therapy in CIDP

Population group: only minors (0 - 18 years old) , adults (18 - 65 years old)

Immunomodulatory therapy in adults, children and adolescents (0-18 years):

Indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

0.2-0.4 g/kg body weight per week

Contraindications

Human normal immunoglobulin G is contraindicated in the following cases:

Patients with hyperprolinaemia type I or II

at least one of

Proline dehydrogenase deficiency
Hyperprolinemia type 2

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