Privigen belongs to the class of medicines called human normal immunoglobulins. Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.

Privigen contains immunoglobulins that have been prepared from the blood of healthy people. The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people.

Privigen is used for the treatment of adults and children (0-18 years) in the following situations:

A) to increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy):

- Patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies (PID)).

- Patients with an acquired immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l.

B) to treat certain inflammatory disorders (immunomodulation). There are 5 groups:

- Patients who do not have enough blood platelets (primary immune thrombocytopenia (ITP) and who are at high risk of bleeding or will have surgery in the near future.

- Patients with Guillain-Barré syndrome. This is an acute disease that is characterised by inflammation of the peripheral nerves that causes severe muscle weakness mainly in the legs and upper limbs.

- Patients with Kawasaki disease. This is an acute disease that primarily affects young children. It is characterised by inflammation of blood vessels throughout the body.

- Patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This is a chronic disease that is characterised by inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and upper limbs.

- Patients with multifocal motor neuropathy (MMN). This is a slowly progressive disease of the motor nerves with weakness of arms and legs.

The active substance is human normal immunoglobulin (antibodies of the type IgG). Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG. The approximate percentage of IgG subclasses is as follows:

IgG₁     69%

IgG₂     26%

IgG₃     3%

IgG₄     2%

This medicine contains trace amounts of IgA (not more than 25 micrograms/ml).

Privigen is sodium free.

The other ingredients (excipients) are the amino acid proline and water for injections.

Privigen is presented as a solution for infusion.

The solution is clear or slightly opalescent and colourless to pale-yellow.

- 1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 40 g/400 ml)

- 3 vials (10 g/100 ml or 20 g/200 ml)

Not all pack sizes may be marketed.