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VARICELLA VACCINE, LIVE

Category Active immunizing agent.

      Live Varicella Vaccine is a freeze-dried preparation of a suitable attenuated strain of Herpesvirus varicellae, propagated in human diploid cells.

      The vaccine, reconstituted as stated on the label, complies with the requirements stated under Vaccines, with the following modifications.

Description The dried vaccine is a white powder or pellet; when reconstituted, it becomes a clear liquid that may be coloured owing to the presence of a pH indicator.

Strengths available Not less than 1000, 1350 or 2000 PFU per 0.5 ml.

Dose Subcutaneous, at deltoid region, 0.5 ml.

Contra-indication

          1. It is contra-indicated in pregnant women; patients with a history of hypersensitivity reactions to this vaccine or any of its components; patients receiving immunosuppressive therapy; patients with blood dyscrasia, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; patients with primary or acquired immunodeficiency, or active untreated tuberculosis; patients with a family history of congenital or hereditary immunodeficiency.

          2. It is not for intravenous administration.

Warning

1. It may cause pain, redness, soreness, swelling or induration at the injection site.

2. Fever, varicella-like maculopapular and/or papulovesicular rash composed of only a few lesions or vesicles may occur.

3. Risk-benefit should be considered if it is to be used in patients with cardiovascular, kidney, liver or hematological disease.

4. It is not recommended for infants.

Precaution

1. Avoid pregnancy for 3 months following vaccination.

2. Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.

Additional information The vaccine may not be effective in those receiving blood or gammaglobulin preparation within 3 months before or after vaccination.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years from the date of the last satisfactory test for potency.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the strain of varicella virus used for the preparation; (2) the type and origin of cells used for the preparation; (3) the nature and quantity of any residual antibiotic present in the vaccine; (4) the minimum virus concentration; (5) that the vaccine is not to be administered to pregnant women; (6) the time within which the vaccine must be used after reconstitution.

Identification When the vaccine reconstituted as stated on the label is mixed with specific Herpesvirus varicellae antibodies, it is no longer able to infect susceptible cell cultures.

Bovine serum albumin Not more than 0.5 μg per single human dose. Carry out the “Immunochemical methods” (Appendix 14.5).

Assay Titrate for infective virus in a suitable cell culture, using at least 10 wells of 96 well plate for each fourfold dilution or by a technique of equal precision. The virus titration is carried out in parallel with the National or International Reference Preparation of Live Varicella Vaccine for comparison. The virus concentration is not less than the minimum stated on the label.

MONOGRAPHS • VARICELLA VACCINE, LIVE
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หมายเหตุ / Note : TP II 2011 PAGE 281