Product information

General Product Information and How to Administer Immunoglobulin (Published August 2020)

general informations

This document was originally published as an immunoglobulin manual in 2008 and the full history of guideline updates can be found on GOV.UK.

Human immunoglobulin preparations prepared by Bio Products Limited (GLP) issued by the UK Health Security Agency (UKHSA) and NHS laboratories are prepared from pooled plasma from non-UK blood donors.

The non-UK plasma pool has been used since March 1999 due to the theoretical risk of transmission of the new variant Creutzfeldt-Jakob disease (nvCJD).

All immunoglobulins are prepared from HIVHepatitis B and C negative donors.

Subgam (human normal immunoglobulin) (HNIG) of the Organic Products Laboratory (GLP) is not licensed for prophylactic use against hepatitis A, measles or rubella. However, the product is known to contain similar levels of measles antibodies to licensed products.

Hepatitis A antibody levels are about half the level of licensing requirements for such a product (although higher than some others available HNIG preparations), but the global supply of suitable products is limited. Therefore UKHSA recommends the use of Subgam for hepatitis A prophylaxis but at a higher dose.

The following preparations for intramuscular use are centrally held by Movianto and ordered through the Rabies and Immunoglobulin Department (RIGS).

Colindale (phone number: 0330 128 1020, 8am-5.30pm) for delivery via ImmForm, as well as some UKHSA and NHS laboratories:

  • human normal immunoglobulin
  • human varicella zoster immunoglobulin
  • human hepatitis B immunoglobulin
  • human rabies immunoglobulin
  • diphtheria antitoxin

The following intramuscular preparations are available and payable via GLP (telephone number: 020 8258 2200, 24 hours):

  • human tetanus immunoglobulin*
  • human anti-D immunoglobulin
  • human hepatitis B immunoglobulin**
  • human rabies immunoglobulin**
  • human varicella-zoster immunoglobulin**

*Only Tetanus Immune Globulin for IM use is now available from GLP. A Tetanus Immune Globulin IV product is no longer available.

**These immunoglobulin preparations are available from UKHSA although they can be purchased directly from GLP when clinicians wish to use them outside of the National Joint Committee on Vaccination and Immunization (JCVI) tips.

Tetanus-specific immunoglobulin (TIG) should be used for the treatment and prevention of tetanus if a suitable supply can be obtained. However, where TIG cannot be obtained, UKHSA recommends that normal human immunoglobulin preparations (IV and IM) can be used. Further details on this are available in Tetanus: advice for healthcare professionals.

Vaccines, antitoxins and immunoglobulins are purchased by the Ministry of Health and Social Affairs (DHSC) specifically for use within the NHS. Similarly, the products distributed by UKHSA on behalf of the department are provided for use within the NHS.

Only patients eligible for NHS treatment (those with an NHS number) can receive immunoglobulin products free of charge. Overseas patients can receive products through an NHS hospital or by temporary registration with a GP.

Private clinics and hospitals are advised to secure stocks of the products they need directly from the manufacturers.

Supplies of normal immunoglobulin for intravenous administration can be obtained from the manufacturers. Details are available in the British National Formulary Index of Manufacturers.

For dosage, precautions, contraindications and side effects, please refer to the individual product information.

Administration of immunoglobulin

When a large volume injection, such as an intramuscular preparation of immunoglobulin, is to be administered, it should be administered deep into a large muscle mass such as the anterolateral aspect of the thigh. The upper outer quadrant of the buttock can also be used for immunoglobulin injection.

If more than 3 ml is to be given to young children and infants or more than 5 ml to older children and adults, the immunoglobulin should be divided into smaller amounts and given to different sites.

Administration of rabies immunoglobulin (PLATFORM)

As much PLATFORM as possible should be infiltrated into the depth of the wound and around the wound site, together with the rest of the PLATFORM given in the anterolateral part of the thigh. When more than 3 ml is to be given to young children or more than 5 ml to older children and adults, the immunoglobulin should be divided and given to different sites.

Vaccine and PLATFORM should never be administered at the same anatomical site, but may be administered on the same day. PLATFORM is not given seven days after onset of rabies DYNAMISM vaccine (or to a person who is already partially immunized).

See specific guidance on administration of rabies immunoglobulin available from GOV.UK.

Normal and specific immunoglobulin

Tips for using normal immunoglobulins for:

  • Hepatitis A
  • measles
  • rubella
  • polio

and specific immunoglobulins for:

  • varicella zoster
  • Hepatitis B
  • rage
  • tetanus

is also contained in Immunization against Infectious Diseases (the Green Book). Further advice on diseases and indications for immunoglobulin should be sought in this publication or in the individual disease advice available on GOV.UK.