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     Anti-D (Rh₀) Immunoglobulin; Anti-D Immunoglobulin; Rh0 (D) Immune Human Globulin; Rh Immune Globulin; Rh₀ (D) IGIM

Category Passive immunizing agent (Immunosuppressive).

          Anti-Rh₀ (D) Immunoglobulin is a liquid or freeze-dried preparation containing human immunoglobulins, mainly immunoglobulin G (IgG). The preparation is intended for intramuscular administration. It is obtained from plasma from D-negative donors immunized against D-antigen. It contains specific antibodies against erythrocyte D-antigen and may also contain small quantities of other bloodgroup antibodies. Immunoglobulin and/or Albumin solution may be added.

          Anti-Rh₀ (D) Immunoglobulin complies with the requirements stated under Immunoglobulin, p.=, except for the minimum total protein content.

          The test for anti-D antibodies (Appendix 15.1.10) is not carried out, since it is replaced by the assay of human anti-D immunoglobulin (Appendix 15.1.9) as prescribed below under Assay.

Description The Anti-Rh₀ (D) Immunoglobulin is clear or slightly opalescent, colourless to pale yellow or light brown solution. The freeze-dried Anti-Rh₀ (D) Immunoglobulin is white to off-white powder.

Stability Liquid Anti-Rh₀ (D) Immunoglobulin should be discarded if it has been frozen. The reconstituted solution of freeze-dried Anti-Rh₀ (D) Immunoglobulin may be stored at room temperature for up to 4 hours. It should be discarded if it is not used within 4 hours.

          Both solutions should not be used if they are discoloured or contain particulate matter.

Strengths available 250 and 1500 IU (50 and 300 μg) per single-dose container.

Dose Intramuscular, 250 or 1500 IU (50 or 300 μg), preferably in the anterolateral aspects of the upper thigh or the deltoid muscle of the upper arm, as prescribed by the physician.

Contra-indication

          1. It is not for intravenous administration.

          2. It is contra-indicated in patients who have had anaphylactic or severe systemic reactions to preparations containing human immunoglobulin.

Warning

          1. It should be administered cautiously to individuals with a specific IgA deficiency since anaphylaxis may occur.

          2. It should be used with caution in individuals with thrombocytopenia or bleeding disorders, since bleeding may occur following intramuscular administration of the drug.

          3. It should be used with caution in individuals with a history of prior systemic allergic reactions to preparations containing human immunoglobulin.

Additional information The antibodies contained in anti-Rh₀ (D) immunoglobulin may interfere with the immune response to some live virus vaccines such as measles, mumps and rubella virus vaccine live, poliovirus vaccine live (oral). These vaccines should be administered at least 3 months after treatment with anti-Rh₀ (D) immunoglobulin. However, postpartum administration of a vaccine containing rubella virus vaccine live to women who are susceptible to rubella should not be delayed because they received antepartum or postpartum anti-Rh₀ (D) immunoglobulin. These women should receive rubella virus vaccines live or measles, mumps and rubella virus vaccine live (MMR) immediately after delivery and serologic tests should be performed 3 months after vaccination to determine if seroconversion occurred.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 1 year from the date of manufacturing, or as indicated on the label.

Packaging and storage Liquid Anti-Rh₀ (D) Immunoglobulin shall be kept in a sealed and colourless glass container, protected from light, and stored at a temperature of 2º to 8º; avoid freezing.

          Freeze-dried Anti-Rh₀ (D) Immunoglobulin shall be kept in a tightly closed colourless glass container, protected from light, and stored at a temperature not exceeding 25º, unless otherwise specified by manufacturers.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states the total number of IU of Anti-Rh₀ (D) Immunoglobulin in the container.

          See also under Immunoglobulin, p. 209.

Assay Carry out the “Biological Assay of Anti-Rh₀ (D) Immunoglobulin” (Method A, Appendix 15.1.6). The estimated potency is not less than 90 per cent of the stated potency. The confidence limits (P = 0.95) are not less than 80 per cent and not more than 120 per cent of the estimated potency.

          Method B or C (Appendix 15.1.6) may be used for potency determination if a satisfactory correlation with the results obtained by Method A has been established for the particular product.