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MEASLES, MUMPS, AND RUBELLA VACCINE, LIVE

MMR (Live)

Category Active immunizing agent.

      Live Measles, Mumps, and Rubella Vaccine is a freeze-dried preparation of a combination of suitable attenuated strains of measles virus, mumps virus and rubella virus such that each component is prepared in conformity with and meets the requirements for Live Measles Vaccine, for Live Mumps Vaccine, and for Live Rubella Vaccine, whichever is applicable.

      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 of measles virus, not less than 5000 or 20,000 CCID50 of mumps virus and not less than 1000 CCID50 of rubella virus 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, sore throat, 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 measles, mumps and rubella virus used in the preparation of the vaccine; (2) where applicable, that chick embryos have been used for the preparation of the vaccine; (3) the type and origin of the cells used for the preparation of the vaccine; (4) the minimum virus concentration for each component of the vaccine; (5) that contact with disinfectants is to be avoided; (6) 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; (7) that both lyophilized and reconstituted vaccines should be protected from light; (8) 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 antibodies specific for measles virus, mumps virus and rubella virus, it is no longer able to infect cell culture susceptible to these viruses. When the reconstituted vaccine is mixed with appropriate amount of specific antibodies sufficient to neutralize any two viral components, the third viral component infects susceptible cell cultures. However, selection of cell cultures susceptible only to mumps and measles, but resisting to rubella can be used instead of rubella neutralization.

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

Ovalbumin If the mumps component is produced in chick embryonated eggs, the vaccine contains not more than 1 μg of ovalbumin per single human dose. Carry out the “Immunochemical Methods” (Appendix 14.5).

Thermal stability Maintain samples of the freeze-dried vaccine in dry state at 37º for 7 days. Determine the virus concentration as described under Assay in parallel for the heated vaccine and for unheated vaccine stored at a temperature between 2º and 8º. For each component, the virus concentration of the heated vaccine is not more than 1.0 log10 lower than that of the unheated vaccine.

Assay

      FOR MEASLES Mix the vaccine with a sufficient quantity of antibodies specific for mumps virus. Titrate the vaccine for infective measles virus at least in triplicate, using at least five cell cultures of susceptible cells such as vero cells 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 measles virus concentration is not less than that stated on the label; the minimum measles virus concentration stated on the label is not less than 1000 CCID50 per single human dose. 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 Measles Vaccine is suitable for use as reference preparation.

      FOR MUMPS Mix the vaccine with a sufficient quantity of antibodies specific for measles virus. Titrate the vaccine for infective mumps virus at least in triplicate, using at least five cell cultures of susceptible cells such as vero cells for each 0.5 log10 dilution step or by amethod of equal precision. Use an appropriate virus reference preparation to validate each assay. The estimated mumps virus concentration is not less than that stated on the label; the minimum mumps virus concentration stated on the label is not less than 5000 or 20,000 CCID50 per single human dose. 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 Mump Vaccine is suitable for use as reference preparation.

      FOR RUBELLA Mix the vaccine with a sufficient quantity of antibodies specific for mumps virus. Titrate the vaccine for infective rubella virus at least in triplicate, using at least five cell cultures of susceptible cells such as RK-13 cells 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. 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 reference preparation.

MONOGRAPHS • MEASLES, MUMPS, AND RUBELLA VACCINE, LIVE
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หมายเหตุ / Note : TP II 2011 PAGE 271-273