GAMMANORM Solution for injection Ref.[27659] Active ingredients: Human normal immunoglobulin G

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration
ATC code: J06BA01

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

Clinical Studies

In two studies, 60 subjects with primary immunodeficiency syndromes, aged 20 to 79 years, were treated with Gammanorm. Each subject was treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment was therefore 6 months for each subject.

The mean dose administered per month was 496.9 mg/kg body weight when given via pump and 476.2 mg/kg body weight when given via syringe. Sustained IgG trough levels with mean concentrations of 9.6 g/L were achieved during the pump treatment sequence and when patients received treatment via syringe, mean IgG concentrations were at 9.4 g/L. Subjects received a mean total of 12.8 Gammanorm infusions per 3-month treatment period during the pump sequence and 34.2 infusions per 3-month treatment period when Gammanorm was administered via syringe.

Paediatric population

No specific studies in the paediatric population were performed with Gammanorm.