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VARICELLA IMMUNOGLOBULIN

Varicella-Zoster Immune Globulin (VZIG)

Category Passive immunizing agent.

          Varicella Immunoglobulin (VIG) is a liquid or freeze-dried preparation containing immunoglobulins, mainly immunoglobulin G (IgG). The preparation is intended for intramuscular administration. It is obtained from plasma from selected donors having antibodies against Herpesvirus varicellae. Immunoglobulin may be added.

          Varicella Immunoglobulin complies with the requirements stated under Immunoglobulin, p. 209, except for the minimum number of donors, the minimum total protein content and, where authorized, the test for antibody to hepatitis B surface antigen and with those under this monograph.

Description The liquid varicella Immunoglobulin is clear or slighty opalescent and colourless or pale yellow.

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

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

Strengths available 125 and 625 IU per single-dose container.

Dose Intramuscular, as prescribed by the physician or as follows:

Contra-indication

          1. It is not for intravenous administration.

          2. It is contra-indicated in patients who have exhibited previous systemic allergic reactions to immunoglobulin, and in those with immunoglobulin A deficiencies and severe thrombocytopenia.

Warning

          1. It is recommended that no more than 125 IU be given in a single injection site.

          2. Swelling, tenderness and pain at the site of intramuscular injection may follow the administration of Varicella Immunoglobulin.

          3. Rapid administration may lead to systemic reactions which include fever, chills, facial flushing, headache, gastro-intestinal and respiratory symptoms.

          4. Severe reactions such as angioedema and anaphylactic shock may occur.

          5. Risk-benefit should be considered if it is to be used in pregnant women.

          6. It is not recommended for use in patients with varicella or herpers zoster infection.

Additional information

          1. It should be administered as soon as possible within 48 hours but not later than 96 hours after exposure to the disease or virus.

          2. Fractional doses of less than 125 IU of Varicella Immunoglobulin are not recommended.

          3. Postexposure prophylaxis with Varicella Immunoglobulin could be repeated at three-week intervals in persons with continued or repeated exposure to varicella until such risk is no longer present.

          4. Antibodies contained in Varicella Immunoglobulin could interfere with the immune response to varicella live virus vaccine, and other certain live virus vaccines such as measles, mumps and rubella including MMR. These vaccines should be administered 5 months or longer after the treatment of Varicella Immunoglobulin. However, there appears to be no interference between Varicella 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 Varicella Immunoglobulin shall be kept in a sealed colourless glass container, protected from light, and stored at a temperature of 2º to 8º; avoid freezing.

          Freeze-dried Varicella Immunoglobulin shall be kept in a sealed 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 Varicella Immunoglobulin in the container.

See also under Immunoglobulin, p. 209.

Assay Carry out the “Immunochemical Method” (Appendix 14.5). The potency is determined by comparing the antibody titer 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 • VARICELLA IMMUNOGLOBULIN
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หมายเหตุ / Note : TP II 2011 PAGE 220-221