Vaccine Information: ProQuad (Page 6 of 6)

15 REFERENCES

  1. Levy O, et al. Disseminated varicella infection due to the vaccine strain of varicella-zoster virus, in a patient with a novel deficiency in natural killer T cells. J Infect Dis. 188(7):948-53, 2003.
  2. Committee on Infectious Diseases, American Academy of Pediatrics. In: Pickering LK, Baker CJ, Overturf GD, et al., eds. Red Book: 2003 Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics. 419-29, 2003.
  3. Peltola H, et al. The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two-dose vaccination program. N Engl J Med. 331(21):1397-1402, 1994.
  4. Bennetto L, Scolding N. Inflammatory/post-infectious encephalomyelitis. J Neurol Neurosurg Psychiatry 2004;75(Suppl 1):i22-8.
  5. Fenichel GM. Neurological complications of immunization. AnnNeurol 1982;12(2):119-28.
  6. Guess HA, et al. Population-based studies of varicella complications. Pediatrics. 78(4 Pt 2):723-727, 1986.
  7. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention. MMWR. 38(22):388-392, 397-400, 1989.
  8. Rubella vaccination during pregnancy–United States, 1971-1986. MMWR Morb Mortal Wkly Rep. 36(28):457-61, 1987.
  9. Rynn L, Cragan J, Correa A. Update on overall prevalence of major birth defects Atlanta, 1978-2005. CDC MMWR. 57(01):1-5, January 11, 2008.
  10. American College of Obstetricians and Gynecologists Frequently Asked Questions: Miscarriage and Molar Pregnancy, 2011.
  11. Bohlke K, Galil K, Jackson LA, et al. Postpartum varicella vaccination: Is the vaccine virus excreted in breast milk? Obstetrics and Gynecology. 102(5):970-977, 2003.
  12. Dolbear GL, Moffat J, Falkner C and Wojtowycz M. A Pilot Study: Is attenuated varicella virus present in breast milk after postpartum immunization? Obstetrics and Gynecology. 101(4 Suppl.):47S-47S, 2003.
  13. Weibel RE, et al. Clinical and laboratory studies of combined live measles, mumps, and rubella vaccines using the RA 27/3 rubella virus. Proc Soc Exp Biol Med. 165(2):323-326, 1980.
  14. Hilleman MR, Stokes J, Jr., Buynak EB, Weibel R, Halenda R, Goldner H. Studies of live attenuated measles virus vaccine in man: II. appraisal of efficacy. Am J Public Health. 52(2):44-56, 1962.
  15. Krugman S, Giles JP, Jacobs AM. Studies on an attenuated measles-virus vaccine: VI. clinical, antigenic and prophylactic effects of vaccine in institutionalized children. N Engl J Med. 263(4):174-7, 1960.
  16. Hilleman MR, Weibel RE, Buynak EB, Stokes J, Jr., Whitman JE, Jr. Live, attenuated mumps-virus vaccine. 4. Protective efficacy as measured in a field evaluation. N Engl J Med. 276(5):252-8, 1967.
  17. Sugg WC, Finger JA, Levine RH, Pagano JS. Field evaluation of live virus mumps vaccine. J Pediatr. 72(4):461-6, 1968.
  18. The Benevento and Compobasso Pediatricians Network for the Control of Vaccine-Preventable Diseases, D’Argenio P, Citarella A, Selvaggi MTM. Field evaluation of the clinical effectiveness of vaccines against pertussis, measles, rubella and mumps. Vaccine. 16(8):818-22, 1998.
  19. Furukawa T, Miyata T, Kondo K, Kuno K, Isomura S, Takekoshi T. Rubella vaccination during an epidemic. JAMA. 213(6):987-90, 1970.
  20. Vazquez M, et al. The effectiveness of the varicella vaccine in clinical practice. N Engl J Med. 344(13):955-960, 2001.
  21. Kuter B, et al. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J. 23(2):132-137, 2004.

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

Storage

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 between58 °F and +5 °F (50 °C and15 °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 and15 °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.

17 PATIENT COUNSELING INFORMATION

Instructions

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)].

Instruct postpubertal females to avoid pregnancy for 3 months following vaccination [see Indications and Usage (1), Contraindications (4.4) and Use in Specific Populations (8.1)].

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.

uspi-v221-i-fro-rha-1909r009

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4171-00
10 Single-dose 0.5-mL Vials

A

Measles, Mumps, Rubella and Varicella
Virus Vaccine Live
ProQuad®

STORE FROZEN

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.

Rx only

Principal Display Panel -- 0.5 mL Vial Carton
(click image for full-size original)
PROQUAD measles, mumps, rubella and varicella virus vaccine live injection, powder, lyophilized, for suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4171
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN (MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN) MEASLES VIRUS STRAIN ENDERS’ ATTENUATED EDMONSTON LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL
MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN (MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN) MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN 20000 [TCID_50] in 0.5 mL
RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN) RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1000 [TCID_50] in 0.5 mL
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN) VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 9772 [PFU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 0.31 mg in 0.5 mL
ALBUMIN BOVINE 0.5 ug in 0.5 mL
GELATIN, UNSPECIFIED 11 mg in 0.5 mL
MONOSODIUM GLUTAMATE 0.4 mg in 0.5 mL
NEOMYCIN 16 ug in 0.5 mL
POTASSIUM CHLORIDE 60 ug in 0.5 mL
DIBASIC POTASSIUM PHOSPHATE 36 ug in 0.5 mL
POTASSIUM PHOSPHATE, MONOBASIC 72 ug in 0.5 mL
SODIUM BICARBONATE 0.17 mg in 0.5 mL
SODIUM CHLORIDE 2.4 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 0.34 mg in 0.5 mL
SORBITOL 1.8 mg in 0.5 mL
SUCROSE 21 mg in 0.5 mL
Product Characteristics
Color YELLOW, PINK (clear pale yellow to light pink) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4171-00 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4171-01)
1 NDC:0006-4171-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4171-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125108 07/01/2015
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 09/2019 Merck Sharp & Dohme Corp.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.