Vaccine reference

M-M-R II (Merck) — official FDA prescribing information, revised 3/2025. Reproduced verbatim from the FDA/DailyMed label. Full label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=252968ca-c714-4c1c-9e60-0b699cb9362f

1 INDICATIONS AND USAGE
M-M-R II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

2 DOSAGE AND ADMINISTRATION (2.1 Dose and Schedule)
A single dose of M-M-R II is approximately 0.5 mL. The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6 years of age. The second dose may be administered prior to 4 years of age, provided that there is a minimum interval of one month between the doses. Children who received an initial dose prior to their first birthday should receive additional doses at 12-15 months and at 4-6 years to complete the series. For post-exposure prophylaxis for measles, administer a dose within 72 hours after exposure.

4 CONTRAINDICATIONS
4.1 Hypersensitivity - Do not administer to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) or who have experienced a hypersensitivity reaction following a previous dose of any measles, mumps and rubella-containing vaccine. Do not administer to individuals with a history of anaphylaxis to neomycin.
4.2 Immunosuppression - Do not administer to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals.
4.3 Moderate or Severe Febrile Illness - Do not administer to individuals with an active febrile illness with fever >101.3F (>38.5C).
4.4 Active Untreated Tuberculosis - Do not administer to individuals with active untreated tuberculosis.
4.5 Pregnancy - Do not administer to individuals who are pregnant or who are planning on becoming pregnant within the next month.

5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure - There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization. For children who have experienced a previous febrile seizure and those with a family history of febrile seizures there is a small increase in risk.
5.2 Hypersensitivity to Eggs - Individuals with a history of anaphylactic or other immediate reactions to egg ingestion may be at enhanced risk of immediate-type hypersensitivity reactions. Evaluate potential risks and known benefits before vaccination.
5.3 Thrombocytopenia - Transient thrombocytopenia has been reported within 4-6 weeks following vaccination. Carefully evaluate risk and benefit in children with thrombocytopenia or who experienced it after a previous dose.
5.4 Family History of Immunodeficiency - Defer vaccination in individuals with a family history of congenital or hereditary immunodeficiency until immune status has been evaluated.
5.5 Immune Globulins and Transfusions - Immune Globulins and other blood products should not be given concurrently, as they may interfere with the expected immune response.

6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during post-approval use of M-M-R II or its individual components: Body as a Whole - panniculitis, atypical measles, fever, headache, dizziness, malaise, irritability. Cardiovascular - vasculitis. Digestive - pancreatitis, diarrhea, vomiting, parotitis, nausea. Hematologic/Lymphatic - thrombocytopenia, purpura, regional lymphadenopathy, leukocytosis. Immune System - anaphylaxis, anaphylactoid reactions, angioedema, bronchial spasm. Musculoskeletal - arthritis, arthralgia, myalgia. Nervous System - encephalitis, encephalopathy, measles inclusion body encephalitis (MIBE), subacute sclerosing panencephalitis (SSPE), Guillain-Barre Syndrome, acute disseminated encephalomyelitis, transverse myelitis, febrile convulsions, afebrile convulsions or seizures, ataxia, polyneuritis, polyneuropathy, ocular palsies, paresthesia, syncope. Respiratory - pneumonia, pneumonitis, sore throat, cough, rhinitis. Skin - Stevens-Johnson syndrome, acute hemorrhagic edema of infancy, Henoch-Schonlein purpura, erythema multiforme, urticaria, rash, measles-like rash, pruritus, injection site reactions. Special Senses Ear - nerve deafness, otitis media. Special Senses Eye - retinitis, optic neuritis, papillitis, conjunctivitis. Urogenital - epididymitis, orchitis. To report suspected adverse reactions, contact Merck at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

11 DESCRIPTION (ingredients)
M-M-R II is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live (attenuated Enders' Edmonston strain, propagated in chick embryo cell culture); (2) Mumps Virus Vaccine Live (Jeryl Lynn strain, propagated in chick embryo cell culture); and (3) Rubella Virus Vaccine Live (Wistar RA 27/3 strain, propagated in WI-38 human diploid lung fibroblasts). After reconstitution, each ~0.5 mL dose contains not less than 3.0 log10 TCID50 of measles virus, 4.1 log10 TCID50 of mumps virus, and 3.0 log10 TCID50 of rubella virus. Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant human albumin (<=0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin, and other buffer and media ingredients. The product contains no preservative.