octagam®10% (Human Normal Immunoglobulin IVIg)

Only available in the UK

United Kingdom

Summary of Product Characteristics octagam® 10%

Patient Information Leaflet octagam® 10%

United Kingdom: Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/UKO10/C/V2 August 2020

This site is intended for UK healthcare professionals and may contain promotional information.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Octapharma by telephoning 0845 1300 522.

Product Information

Summary of Product Characteristics octagam® 10%

Therapeutic Indicatons

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

  • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

  • Multifocal motor neuropathy (MMN)

Shelf Life & Storage

Shelf life is two years.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the container in the outer carton in order to protect from light.

The product may be removed from the refrigerator for a single period of up to 9 months (without exceeding the expiry date) and stored at a temperature below 25°C. At the end of this period, the product should not be refrigerated again and should be disposed of. The date at which the product was taken out of the refrigerator should be recorded on the outer carton.

Available in vials of:

Our licensed vial sizes are listed below:

One ml contains: Human normal immunoglobulin (IVIg) 100 mg

  • Each vial of 20 ml contains 2g of human normal immunoglobulin.

  • Each bottle of 50 ml contains 5g of human normal immunoglobulin.

  • Each bottle l of 60 ml contains 6g of human normal immunoglobulin.

  • Each bottle of 100 ml contains 10g of human normal immunoglobulin.

  • Each bottle of 200 ml contains 20g of human normal immunoglobulin.

  • Each bottle of 300 ml contains 30g of human normal immunoglobulin.

For questions about availability please contact customer services.


Legal classification: Prescription-only Medicine

Basic NHS cost: £69.00 per gram


UK/P/UKO10HCP/C/V3 August 2020