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M-R-Vax II

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M-R-Vax

Indications
Dosage
How Supplied

INDICATIONS

M-R-VAX (measles and rubella virus vaccine live) II is indicated for simultaneous immunization against measles and rubella in persons 15 months of age or older. A second dose of M-R-VAX (measles and rubella virus vaccine live) II or monovalent measles vaccine is recommended (see Revaccination  ).

Infants who are less than 15 months of age may fail to respond to the measles component of the vaccine due to presence in the circulation of residual measles antibody of maternal origin; the younger the infant, the lower the likelihood of seroconversion. In geographically isolated or other relatively inaccessible populations for whom immunization programs are logistically difficult, and in population groups in which natural measles infection may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. Infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 15 months of age. There is some evidence to suggest that infants immunized at less than one year of age may not develop sustained antibody levels when later reimmunized. The advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunization.

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 a 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 reason 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.

Postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination (see ADVERSE REACTIONS ).

Postpartum Women

It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period. (See Nursing Mothers ).

Revaccination:   Children first vaccinated when younger than 12 months of age should be revaccinated at 15 months of age.

The American Academy of Pediatrics (AAP), the Immunization Practices Advisory Committee (ACIP), and some state and local health agencies have recommended guidelines for routine measles revaccination and to help control measles outbreaks. ****

Vaccines available for revaccination include monovalent measles vaccine [ATTENUVAX (Measles Virus Vaccine Live)] and polyvalent vaccines containing measles [e.g., M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live), M-R-VAX (measles and rubella virus vaccine live) II]. If the prevention of sporadic measles outbreaks is the sole objective, revaccination with a monovalent measles vaccine should be considered (see appropriate product circular). If concern also exists about immune status regarding mumps or rubella, revaccination with appropriate monovalent or polyvalent vaccines should be considered after consulting the appropriate product circulars. Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian.

 

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 M-R-VAX (measles and rubella virus vaccine live) II.

M-R-VAX (measles and rubella 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."

**** NOTE:  A primary difference among these recommendations is the timing of revaccination: the ACIP recommends routine revaccination at entry into Kindergarten or first grade, whereas the AAP recommends routine revaccination at entrance to middle school or junior high school. In addition, some public health jurisdictions mandate the age for revaccination. The complete text of applicable guidelines should be consulted.

 

DOSAGE AND ADMINISTRATION

FOR SUBCUTANEOUS ADMINISTRATION

Do not inject intravenously

The dosage of vaccine is the same for all persons. Inject the total volume of the single dose vial (about 0.5 mL) or 0.5 mL of the multiple dose vial of reconstituted vaccine subcutaneously, preferably into the outer aspect of upper arm. Do not give immune globulin (IG) concurrently with M-R-VAX (measles and rubella 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 M-R-VAX (measles and rubella 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 and/or reconstitution 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.

Single Dose Vial   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 and other infectious agents from one person to another.

10 Dose Vial (available only to government agencies/institutions)   Withdraw the entire contents (7 mL) of the diluent vial into the sterile syringe to be used for reconstitution, and introduce into the 10 dose vial of lyophilized vaccine. Agitate to ensure thorough mixing. The outer labeling suggests "For Jet Injector or Syringe Use". Use with separate sterile syringes is permitted for containers of 10 doses or less. The vaccine and diluent do not contain preservatives; therefore, the user must recognize the potential contamination hazards and exercise special precautions to protect the sterility and potency of the product. The use of aseptic techniques and proper storage prior to and after restoration of the vaccine and subsequent withdrawal of the individual doses is essential. Use 0.5 mL of the reconstituted vaccine for subcutaneous injection.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another.

50 Dose Vial (available only to government agencies/institutions)  Withdraw the entire contents (30 mL) of diluent vial into the sterile syringe to be used for reconstitution and introduce into the 50 dose vial of lyophilized vaccine. Agitate to ensure thorough mixing. With full aseptic precautions, attach the vial to the sterilized multidose jet injector apparatus. Use 0.5 mL of the reconstituted vaccine for subcutaneous injection.

Each dose contains not less than the equivalent of 1,000 TCID 50 of the U.S. Reference Measles Virus and 1,000 TCID 50 of the U.S. Reference Rubella Virus.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. M-R-VAX (measles and rubella virus vaccine live) II, when reconstituted, is clear yellow.

 

HOW SUPPLIED

No. 4751 M-R-VAX (measles and rubella virus vaccine live) II is supplied as a single-dose vial of lyophilized vaccine, NDC 0006-4751-00, and a vial of diluent.

No. 4677/4309 M-R-VAX (measles and rubella virus vaccine live) II is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4677-00; and (2) a box of 10 vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature

(6505-01-098-8004, Ten Pack).

Available only to government agencies/institutions:

No. 4678 M-R-VAX (measles and rubella virus vaccine live) II is supplied as one 10 dose vial of lyophilized vaccine, NDC 0006-4678-00, and one 7 mL vial of diluent.

No. 4679 M-R-VAX (measles and rubella virus vaccine live) II is supplied as one 50 dose vial of lyophilized vaccine, NDC 0006-4679-00, and one 30 mL vial of diluent

(6505-01-098-8005, 50 dose).

Storage

It is recommended that the vaccine be used as soon as possible after reconstitution. Protect 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 8 hours.

A.H.F.S. Category: 80:12
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.

Indications
Dosage
How Supplied
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