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(P.J.S)

Intratect® (50 and 100 g/l)

Clinical Immunology

Human normal immunoglobulin (IVIg)

The active ingredient of Intratect is human immunoglobulin for intravenous administration. Intratect contains 50 g/l or 100 g/l of human normal immunoglobulin, of which at least 96 % is immunoglobulin G (IgG).

Intratect is used in adults and in children and adolescents (0-18 years) without sufficient antibodies as replacement therapy in:

  • Patients who have been deficient in antibodies since birth (primary immunodeficiency syndromes).
  • Patients with proven specific antibody deficiency or an IgG level of 4 g/l who suffer from severe or recurrent infections and ineffective antimicrobial treatment with antibody deficiency (secondary immunodeficiency syndromes).

Intratect is also used in adults and in children and adolescents (0-18 years) for the treatment of inflammatory diseases (immunomodulation), such as:

  • Primary immune thrombocytopenia (ITP, in which the patient has a decreased number of platelets), when the patient is scheduled for surgery shortly or is at risk for bleeding.
  • Guillain-Barré syndrome (a disease that damages the nerves and can cause generalized paralysis)
  • Kawasaki disease (a disease in children that causes inflammation of multiple organs in the body and causes the arteries in the heart to dilate) along with acetylsalicylic acid.
  • Chronic Inflammatory Demyelinating polyneuropathy (CIDP); this is a chronic disease characterized by the inflammation of the peripheral nerves causing muscle weakness and/or numbness mainly in the legs and upper limbs and.
  • Multifocal Motor Neuropathy (MMN); this is a rare disorder characterized by slowly progressive asymmetric weakness of the limbs without sensory loss.

For Intratect 50 g/l:

A pack of 1 vial containing 1 g in 20 ml solution

A pack of 1 vial containing 2.5 g in 50 ml solution

A pack of 1 vial containing 5 g in 100 ml solution

For Intratect 100 g/l:

pack of 1 vial containing 5 g in 50 ml solution,

A pack of 1 vial containing 10 g in 100 ml solution

Intratect is intended for intravenous administration. Keep the vial inside the container to protect it from light. Don’t store it at +25°C and don’t freeze it.

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