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HEPATITIS B IMMUNOGLOBULIN

          Hepatitis B Immune Globulin; Human Hepatitis B Immunoglobulin; HBIG

Category Passive immunizing agent.

          Hepatitis B Immunoglobulin is a liquid or freezedried preparation containing immunoglobulins, mainly immunoglobulin G (IgG). The preparation is intended for intramuscular administration. It is obtained from plasma from selected and/or immunized donors having antibodies against hepatitis B surface antigen. Immunoglobulin may be added.

          Hepatitis B Immunoglobulin complies with the requirements stated under Immunoglobulin, p. 209, except for the minimum total protein content, and with those under this monograph.

Description The liquid Hepatitis B Immunoglobulin is clear or slightly opalescent and colourless or pale yellow to light brown.

          The freeze-dried Hepatitis B Immunoglobulin is a white or slightly yellow powder or solid friable mass.

Stability Liquid Hepatitis B Immunoglobulin should be discarded if it has been frozen. The reconstituted solution of freeze-dried Hepatitis B Immunoglobulin should be used immediately or as stated on the label.

Strengths available 100, 180, 200, and 220 IU per ml.

Dose Adults and children over 10 years of age: Intramuscular, 500 IU as a single dose.

          Children 5 to 10 years of age: Intramuscular, 300 IU as a single dose.

          Children under 5 years of age and infants: Intramuscular, 200 IU as a single dose.

Contra-indication It is not for intravenous administration.

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. Local pain, tenderness, swelling, and erythema may occur at the injection site.

          4. Risk-benefit should be considered if it is to be used in nursing women.

          5. Urticaria, rash, pruritus, angioedema, nausea, faintness, fever, body and joint pains, dizziness, leg cramps, or malaise and lassitude may occur.

Additional information

          1. It should be administered as soon as possible within 48 hours and not more than 1 week after exposure to the virus for adults and children over 10 years of age or within 48 hours of birth of hepatitis B infected mothers.

          2. It should be administered at different sites when administering concomitantly with hepatitis B vaccine.

          3. The antibodies in hepatitis B immunoglobulin preparations may interfere with the immune responses to certain live virus vaccines such as measles, mumps and rubella including MMR. These vaccines should be administered at least 14 days before or 3 months after treatment with hepatitis B immunoglobulin. However, there appears to be no interference between hepatitis B immunoglobulin and oral poliomyelitis vaccine (OPV),yellow fever vaccine or oral typhoid (strain Ty 21a) vaccine.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years from the date of manufacturing, or as indicated on the label.

Packaging and storage Liquid Hepatitis B 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 Hepatitis B Immunoglobulin shall be kept in a sealed and 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 number of IU per container.

          See also under Immunoglobulin, p. 205.

Assay Carry out the “Immunochemical Methods (Appendix 14.5). The potency is determined by comparing the antibody titre of the immunoglobulin to be examined with that of a standard preparation calibrated in International Units, using an immunoassay of suitable sensitivity and specificity.

          The stated potency is not less than 100 IU per ml. The estimated potency is not less than the stated potency. The confidence limits (P = 0.95) are not less than 80 per cent and not more than 125 per cent of the estimated potency.

MONOGRAPHS • HEPATITIS B IMMUNOGLOBULIN
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หมายเหตุ / Note : TP II 2011 PAGE 215-216