สารบัญ

Category Active immunizing agent.

      Live Rubella Vaccine is a freeze-dried preparation of a suitable attenuated strain of rubella virus, propagated in human diploid cells. The vaccine does not contain any added preservative.

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

Description Solid having the characteristic appearance of substances dried from frozen state. When reconstituted, it becomes a clear liquid that may be coloured owing to the presence of a pH indicator.

Stability The reconstituted solution of freeze-dried vaccine should be stored at a temperature between 2º and 8º, protected from light. Discoloured or cloudy solutions should not be used. Discard unused reconstituted vaccine after 8 hours.

Strength available Not less than 1000 CCID₅₀ per 0.5 ml.

Dose Subcutaneous, preferably into the outer aspect of the upper arm, 0.5 ml.

Contra-indication; Precaution; Additional information See under Measles Vaccine, Live, p. 258.

Warning Rubella-like symptoms (mild regional lymphadenopathy, rash, urticaria, fever, malaise, sorethroat, dizziness, headache, nausea, vomiting, diarrhea, general aches, and polyneuritis) may occur 11 to 20 days after vaccination and are usually mild and transient, generally persisting 1 to 5 days.

      See also under Measles Vaccine, Live, p. 258.

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

Labelling Complies with the labelling described under the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the strain of rubella virus used for the preparation of the vaccine; (2) the type and origin of the cells used for the preparation of the vaccine; (3) the minimum virus concentration contained in one recommended human dose; (4) that after reconstitution it should be used without delay or, if not used immediately, stored between 2º and 8º for a period not exceeding 8 hours; (5) that contact with disinfectants is to be avoided; (6) that the vaccine must not be given to a pregnant woman and that a woman must not become pregnant within 3 months after having the vaccine.

Identification When the reconstituted vaccine is mixed with an appropriate amount of specific rubella antibodies, it is no longer able to infect susceptible cell cultures.

Bovine serum albumin Not more than 50 ng per single human dose. Carry out the “Immunochemical Methods” (Appendix 14.5).

Assay Titrate the vaccine for infective virus at least in triplicate, using at least five cell cultures for each 0.5 log₁₀ dilution step or by a method of equal precision. Use an appropriate virus reference preparation to validate each assay. The estimated rubella virus concentration is not less than that stated on the label; the minimum rubella virus concentration stated on the label is not less than 1000 CCID₅₀ per single human dose (0.5 ml). The assay is not valid if the confidence interval (P = 0.95) of the logarithm of the virus concentration is more than ±0.3.

      National or International Reference Preparation of Live Rubella Vaccine is suitable for use as a reference preparation.