IMMUNOGLOBULIN HUMAN anti-D, 300µg, powder + diluent, vial

STD DVACIMHD1V-

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
11.2.1 - Human immunoglobulins
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J06BB01
Anatomical Therapeutic Chemical Classification according to WHOCC
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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IMMUNOGLOBULIN HUMAN anti-D

Therapeutic Action

Anti-D (Rh) immunoglobulin contains specific antibodies (IgG) against the Rh(D) antigen of human erythrocytes.

Indications

Rh(D) immunisation following pregnancy can be prevented in most cases by giving a dose of anti-D immunoglobulin (anti-D Ig) to Rh(D) negative mothers after delivery of a Rh(D) positive infant, after stillbirth or abortion or any other potentially sensitising event during pregnancy.

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Instructions for use

One ml contains 150 micrograms (750 IU) human anti-D immunoglobulin.

Must be given by slow IV or IM injection.

The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D)-positive red blood cells (RBCs) and based on the knowledge that 0.5 ml of Rh(D)-positive RBCs or 1 ml of Rh(D)-positive blood is neutralised by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.

Precautions for Use

Anti-D immunoglobulin is intended for maternal administration. Do not administer to the new-born infant.

Do not administer in Rh(D) positive individuals, nor in individuals already immunised to Rh(D) antigen.

As with all injectable vaccines and/or immunoglobulins, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the product.

Storage

  • Pre-filled syringe: keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • Powder + diluent: below 25°C - Protect from sunlight
  • Do not freeze.

(Cf Introduction: Thermosensitive products)