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No. 4171 — ProQuad is supplied as follows:
(1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4171-00 (package A)
(2) a separate package of 10 vials of sterile water diluent (package B).
To maintain potency, ProQuad must be stored frozen between -58°F and +5°F (-50°C to -15°C). Use of dry ice may subject ProQuad to temperatures colder than -58°F (-50°C).
Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between −58 °F and +5 °F ( −50 °C and −15 °C) for up to 18 months. Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature between −58 °F and +5 °F ( −50 °C and −15 °C) and has a separate sealed freezer door is acceptable for storing ProQuad. Routine defrost cycling of a frost-free freezer is acceptable.
ProQuad may be stored at refrigerator temperature (36° to 46°F, 2° to 8°C) for up to 72 hours prior to reconstitution. Discard any ProQuad vaccine stored at 36° to 46°F which is not used within 72 hours of removal from 5°F (-15°C) storage.
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.
DO NOT FREEZE RECONSTITUTED VACCINE.
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 the product or questions regarding storage conditions, call 1-800-MERCK-90.
Provide the required vaccine information to the patient, parent, or guardian.
Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
Inform the patient, parent, or guardian that the vaccine recipient should avoid use of salicylates for 6 weeks after vaccination with ProQuad [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].
Inform patients, parents, or guardians that vaccination with ProQuad may not offer 100% protection from measles, mumps, rubella, and varicella infection.
Instruct patients, parents, or guardians to report any adverse reactions to their health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at http://www.vaers.hhs.gov.
Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2005-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton
10 Single-dose 0.5-mL Vials
Measles, Mumps, Rubella and Varicella
Virus Vaccine Live
Measles vaccine: More attenuated Enders’ Edmonston strain. Chick cell tissue culture origin.
Mumps vaccine: Jeryl Lynn™ strain. Chick cell tissue culture origin.
Rubella vaccine: Wistar RA 27/3 strain. Human diploid cell (WI-38) culture origin.Varicella vaccine: Oka/Merck strain. Human diploid cell (MRC-5) culture origin.
Contains no preservative. Contains trace quantities of neomycin.
|PROQUAD measles, mumps, rubella and varicella virus vaccine live injection, powder, lyophilized, for suspension|
|Labeler — Merck Sharp & Dohme Corp. (001317601)|
Revised: 09/2019 Merck Sharp & Dohme Corp.
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