Clinical Information
Gen. Code and Des.
63856 measles,mumps,rubella vacc/PF SUBCUT VIAL 12500/0.5
GCN and Des.
99568 measles,mumps,rubella vacc/PF SUBCUT VIAL 12500/0.5
Strength
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
3116 measles, mumps, and rubella vaccine live
9870 preservative free
Inactive Ingredients
2549 gelatin 9000708
2598 sucrose 57501
2599 sorbitol 50704
9283 beef derived (bovine)
Strength: 1,000-12,500-1,000 TCID50/0.5 mL
M-M-R II- measles virus strain enders" attenuated edmonston live antigen, mumps virus strain b level jeryl lynn live antigen and rubella virus strain wistar ra 27/3 live antigen injection, powder, lyophilized, for suspension
A-S Medication Solutions
DESCRIPTION
M-M-R� II (Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola), mumps, and rubella (German measles).
M-M-R II is a sterile lyophilized preparation of (1) ATTENUVAX� (Measles Virus Vaccine Live), a more attenuated line of measles virus, derived from Enders" attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX� (Mumps Virus Vaccine Live), the Jeryl Lynn� (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX� II (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts.{1,2}
The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as stabilizer and neomycin.
The growth medium for rubella is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing recombinant human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.
The cells, virus pools, and fetal bovine serum are all screened for the absence of adventitious agents.
The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus; 12,500 TCID50 of mumps virus; and 1,000 TCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.
Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. M-M-R II, when reconstituted as directed, is clear yellow.
CLINICAL PHARMACOLOGY
Measles, mumps, and rubella are three common childhood diseases, caused by measles virus, mumps virus (paramyxoviruses), and rubella virus (togavirus), respectively, that may be associated with serious complications and/or death. For example, pneumonia and encephalitis are caused by measles. Mumps is associated with aseptic meningitis, deafness and orchitis; and rubella during pregnancy may cause congenital rubella syndrome in the infants of infected mothers.
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION
Do not inject intravascularly.
The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm.
The recommended age for primary vaccination is 12 to 15 months.
Revaccination with M-M-R II is recommended prior to elementary school entry. See also INDICATIONS AND USAGE, Recommended Vaccination Schedule.
Children first vaccinated when younger than 12 months of age should receive another dose between 12 to 15 months of age followed by revaccination prior to elementary school entry.{32} See also INDICATIONS AND USAGE, Measles Outbreak Schedule.
Immune Globulin (IG) is not to be given concurrently with M-M-R II (see PRECAUTIONS, General and PRECAUTIONS, Drug Interactions).
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″ 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. If the lyophilized vaccine cannot be dissolved, discard. 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. M-M-R II, when reconstituted, is clear yellow.
