ProQuad is a measles, mumps, rubella and varicella virus vaccine. Measles, mumps, rubella, and varicella are serious diseases caused by viruses. They are spread from person to person through the air. PROQUAD- measles virus strain enders' attenuated edmonston live antigen, mumps virus strain b level jeryl lynn live antigen, rubella virus strain wistar ra 27/3 live antigen and varicella-zoster virus strain oka/merck live antigen injection, powder, lyophilized, for suspension
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
ProQuad� is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Schedule
FOR SUBCUTANEOUS ADMINISTRATION ONLY
Each 0.5-mL dose of ProQuad is administered subcutaneously.
The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.
If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R� II (measles, mumps, and rubella virus vaccine live) and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.
2.2 Preparation for Administration
CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents, and other anti-viral substances for reconstitution and injection of ProQuad.
Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives or other anti-viral substances.
Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.
Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.
TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
2.3 Method of Administration
Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.
Use With Other Vaccines
Use different injection sites to administer each vaccine if other vaccines are administered concomitantly. [See Drug Interactions (7.5).]
3 DOSAGE FORMS AND STRENGTHS
ProQuad is a suspension for injection supplied as a 0.5-mL single dose vial of lyophilized vaccine to be reconstituted using the sterile diluent supplied [see How Supplied/Storage and Handling (16)].
