Product Details

Pharmaceutical form

Solution for infusion

Therapeutic indications

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

- Primary immunodeficiency syndromes (PID) 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 <4g/l.
*PSAF=failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines

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

- Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
- Guillain Barré syndrome
- Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2)
- Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
- Multifocal motor neuropathy (MMN)

Contraindications

- Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients
- Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.

Special warnings and precautions for use

This medicinal product contains 100 mg of maltose per ml as an excipient. The interference of maltose in blood glucose assays may result in falsely elevated glucose readings

Traceability

Potential complications can often be avoided by ensuring that patients:

- are not sensitive to human normal immunoglobulin by initially injecting the product slowly (1 ml/kg/hour)
- are carefully monitored for any symptoms throughout the infusion period.
 
In order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

In all patients, IVIg administration requires:

- adequate hydration prior to the initiation of the infusion of IVIg
- monitoring of urine output
- monitoring of serum creatinine levels
- avoidance of concomitant use of loop diuretics.

Shelf life

2 years

Special precautions for storage

- Store below 25°C. Do not freeze.
- Keep container in the outer carton in order to protect from light.
- Do not use after expiry date.

Reference

Octagam® 5% - Summary of product characteristics