"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
DOSAGE AND ADMINISTRATION
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.
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.
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
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 Storage and Handling].
Storage And Handling
No. 4993 — ProQuad is supplied as follows:
- a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4993-41 (package A)
- a separate package of 10 vials of sterile water diluent (package B).
During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 2° to 8°C (36° to 46°F) or colder.
Before reconstitution, store the lyophilized vaccine in a refrigerator at 2° to 8°C (36° to 46°F) or colder. The lyophilized vaccine may also be stored in a freezer and subsequently transferred to a refrigerator; however, the lyophilized vaccine should not be refrozen.
DO NOT STORE LYOPHILIZED VACCINE AT ROOM TEMPERATURE.
IF LYOPHILIZED VACCINE IS INADVERTENTLY STORED AT ROOM TEMPERATURE, IT SHOULD BE DISCARDED.
Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.
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.
Diluent should be stored separately at room temperature (68° to 77°F, 20° to 25°C), or in a refrigerator (36° to 46°F, 2° to 8°C).
For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.
Dist. by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: Feb 2014
Last reviewed on RxList: 9/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Proquad Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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