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Rh₀ (D) Immune Globulin IV; Rh₀ (D) IGIV

Category Passive immunizing agent (immunosuppressive).

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

          Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration complies with the requirements stated under Human Normal Immunoglobulin for Intravenous Administration, p. 211, except for the minimum total protein content, the limit for osmolality and the limit for prekallikrein activator.

          The test for anti-D antibodies (Appendix 15.1.10) is not carried out, since it is replaced by the assay of anti-Rh₀ (D) immunoglobulin (Appendix 15.1.6) as prescribed below under Assay.

Description The Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration is clear or slightly opalescent, colourless to pale yellow solution.

          The freeze-dried Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration is white to off-white lyophilized powder.

Stability Liquid Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration should be discarded if it has been frozen. The reconstituted solution of freezedried Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration 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 600, 1500, 2500, 5000 and 15,000 IU (120, 300, 500, 1000, and 3000 μg) per single-dose container.

Dose Intravenous, should be given over 3 to 5 minutes, or intramuscular, preferably in the anterolateral aspects of the upper thigh or the deltoid muscle of the upper arm, as prescribed by the physician.

Contra-indication 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 a history of prior systemic allergic reactions to preparations containing human immunoglobulin.

Additional information The antibodies contained in anti-Rh₀ (D) immunoglobulin for intravenous administration 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 for intravenous administration. 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 for intravenous administration. 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 3 years from the date of manufacturing, or as indicated on the label.

Packaging and storage Liquid Anti-Rh₀ (D) Immunoglobulin for Intravenous Administration 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 for Intravenous Administration 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 Human Normal Immunoglobulin for Intravenous Administration, p. 212.

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.