"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Previously unimmunized children of susceptible pregnant women should receive live attenuated rubella vaccine, because an immunized child will be less likely to acquire natural rubella and introduce the virus into the household.
Individuals planning travel outside the United States, if not immune, can acquire measles, mumps or rubella and import these diseases to the United States. Therefore, prior to International travel, individuals known to be susceptible to one or more of these diseases can receive either a single antigen vaccine (measles, mumps, or rubella), or a combined antigen vaccine as appropriate. However, M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live) is preferred for persons likely to be susceptible to mumps and rubella; and if single-antigen measles vaccine is not readily available, travelers should receive M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) regardless of their immune status to mumps or rubella.
Non-Pregnant Adolescent and Adult Females
Immunization of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see below and PRECAUTIONS). Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the fetus and consequent congenital rubella injury.
Women of childbearing age should be advised not to become pregnant for three months after vaccination and should be informed of the reasons for this precaution.**
It is recommended that rubella susceptibility be determined by serologic testing prior to immunization.***
If immune, as evidenced by a specific rubella antibody titer of 1:8 or greater (hemagglutination-inhibition test), vaccination is unnecessary. Congenital malformations do occur in up to seven percent of all live births. Their chance appearance after vaccination could lead to misinterpretation of the cause, particularly if the prior rubella-immune status of vaccinees is unknown.
It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period. (See Nursing Mothers ).
Revaccination: Children vaccinated when younger than 12 months of age should be revaccinated. Based on available evidence, there is no reason to routinely revaccinate persons who were vaccinated originally when 12 months of age or older. However, persons should be revaccinated if there is evidence to suggest that initial immunization was ineffective.
Use with other Vaccines
Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concomitantly with measles, mumps and rubella vaccines is not recommended because there are insufficient data relating to the simultaneous administration of these antigens. However, the American Academy of Pediatrics has noted that in some circumstances, particularly when the patient may not return, some practitioners prefer to administer all these antigens on a single day. If done, separate sites and syringes should be used for DTP and BIAVAX (rubella and mumps virus vaccine live) II.
BIAVAX (rubella and mumps virus vaccine live) II should not be given less than one month before or after administration of other virus vaccines.
*Registered trademark of MERCK & CO., INC.
**NOTE: The Immunization Practices Advisory Committee (ACIP) has recommended "In view of the importance of protecting this age group against rubella, reasonable precautions in a rubella immunization program include asking females if they are pregnant, excluding those who say they are, and explaining the theoretical risks to the others."
***NOTE: The Immunization Practices Advisory Committee (ACIP) has stated "When practical, and when reliable laboratory services are available, potential vaccinees of childbearing age can have serologic tests to determine susceptibility to rubella. . . . However, routinely performing serologic tests for all females of childbearing age to determine susceptibility so that vaccine is given only to proven susceptibles is expensive and has been ineffective in some areas. Accordingly, the ACIP believes that rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing."
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION
Do not inject intravenously.
The dosage of vaccine is the same for all persons. Inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of upper arm. Do not give immune globulin (IG) concurrently with BIAVAX (rubella and mumps virus vaccine live) II.
During shipment, to insure that there is no loss of potency, the vaccine must be maintained at a temperature of 10°C (50°F) or less.
Before reconstitution, store BIAVAX (rubella and mumps virus vaccine live) II at 2-8°C (36-46°F). Protect from light.
CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 5 / 8 [Prime ] needle is recommended.
To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine. First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.
It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B virus and other infectious agents from one person to another.
Each dose of BIAVAX (rubella and mumps virus vaccine live) II contains not less than the equivalent of 1,000 TCID 50 of the U.S. Reference Rubella Virus and 20,000 TCID 50 of the U.S. Reference Mumps Virus.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. BIAVAX (rubella and mumps virus vaccine live) II, when reconstituted, is clear yellow.
No. 4746 BIAVAX (rubella and mumps virus vaccine live) II is supplied as a single-dose vial of lyophilized vaccine, NDC 0006-4746-00, and a vial of diluent.
No. 4669/4309 BIAVAX (rubella and mumps virus vaccine live) II is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4669-00; and (2) a box of 10 vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature.
It is recommended that the vaccine be used as soon as possible after reconstitution. Protect the vaccine from light at all times, since such exposure may inactivate the virus. Store reconstituted vaccine in the vaccine vial in a dark place at 2-8°C (36-46°F) and discard if not used within eight hours.
COPYRIGHT © MERCK & CO., INC., 1990
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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