Indications

M-M-R®II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

The ACIP recommends administration of the first dose of M-M-R®II at 12 to 15 months of age and administration of the second dose of M-M-R®II at 4 to 6 years of age.

Selected Safety Information for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic or anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary or acquired immunodeficiency conditions; family history of congenital or hereditary immunodeficiency or receiving immunosuppressive therapy; an active febrile illness; or those who are pregnant. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Due caution should be employed in administration of M-M-R®II to persons with: a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; thrombocytopenia.

The following adverse reactions have been reported with M-M-R®II without regard to causality: fever, headache, dizziness, rash, injection-site reactions, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, and thrombocytopenia. Additional adverse reactions, which have been reported without regard to causality, include encephalitis and encephalopathy in their diverse clinical presentations.

Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).

As for any vaccine, vaccination with M-M-R®II may not result in protection in 100% of vaccinees.

Dosage and Administration

FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.

Immune globulin (IG) is not to be given concurrently with M-M-R®II.

M-M-R®II should be given one month before or after administration of other live viral vaccines. M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live) and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.

Before administering M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), please read the Prescribing Information. The Patient Information also is available.

1. Centers for Disease Control and Prevention (CDC). Vaccine Storage & Handling Toolkit. http://www.cdc.gov/vaccines/hcp/admin/storage/
toolkit/storage-handling-toolkit.pdf. Published June 2016. Accessed March 24, 2017.
2. Centers for Disease Control and Prevention (CDC). Milestones in the history of vaccination. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th rev ed. Washington, DC: Public Health Foundation; 2015:ii–xi.
3. Food and Drug Administration (FDA). Center for
Biologics Evaluation and Research (CBER). CBER clinical review of studies submitted in support of licensure of ProQuad™. http://www.fda.gov/downloads/
biologicsbloodvaccines/vaccines/
approvedproducts/ucm123800.pdf. Effective August 26, 2005. Accessed March 24, 2017.
4. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/
child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2017. Accessed March 24, 2017.

Storage and Handling

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).

Storage

  • To maintain potency, M-M-R®II must be stored between -58°F and +46°F (-50°C to +8°C).
  • Use of dry ice may subject M-M-R®II to temperatures colder than -58°F (-50°C).
  • Before reconstitution, store the lyophilized vaccine at 36°F to 46°F (2°C to 8°C).
  • Protect the vaccine from light at all times, since such exposure may inactivate the viruses.
  • The diluent may be stored in the refrigerator with the lyophilized vaccine or separately at room temperature. DO NOT FREEZE the diluent.
  • For storage following reconstitution, see “Handling” below.

Handling

  • To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances that might inactivate the vaccine.
  • It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in a dark place at 36°F to 46°F (2°C to 8°C) and discard if not used within 8 hours.
  • 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. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The vaccine, when reconstituted, is clear yellow.
  • For information regarding stability under conditions other than those recommended, call 800.MERCK.90 (800.637.2590).

General Tips

  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.1
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another.
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
See CDC.gov for additional general vaccine tips.

CDC=Centers for Disease Control and Prevention.

Indications

M-M-R®II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

The ACIP recommends administration of the first dose of M-M-R®II at 12 to 15 months of age and administration of the second dose of M-M-R®II at 4 to 6 years of age.

Selected Safety Information for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic or anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary or acquired immunodeficiency conditions; family history of congenital or hereditary immunodeficiency or receiving immunosuppressive therapy; an active febrile illness; or those who are pregnant. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Due caution should be employed in administration of M-M-R®II to persons with: a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; thrombocytopenia.

The following adverse reactions have been reported with M-M-R®II without regard to causality: fever, headache, dizziness, rash, injection-site reactions, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, and thrombocytopenia. Additional adverse reactions, which have been reported without regard to causality, include encephalitis and encephalopathy in their diverse clinical presentations.

Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).

As for any vaccine, vaccination with M-M-R®II may not result in protection in 100% of vaccinees.

Dosage and Administration

FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.

Immune globulin (IG) is not to be given concurrently with M-M-R®II.

M-M-R®II should be given one month before or after administration of other live viral vaccines. M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live) and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.

Before administering M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), please read the Prescribing Information. The Patient Information also is available.

VACC-1159574-0004 09/17