Vaccine Information: VAQTA (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for Vaccine Recipients and Parents or Guardians

  • Inform the patient, parent or guardian of the potential benefits and risks of the vaccine.
  • Question the vaccine recipient, parent, or guardian about the occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of hepatitis A vaccine.
  • Inform the patient, parent, or guardian about the potential for adverse events that have been temporally associated with administration of VAQTA.
  • Tell the patient, parent, or guardian accompanying the recipient, to report adverse events to the physician or clinic where the vaccine was administered.
  • Prior to vaccination, give the patient, parent, or guardian the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
  • Tell the patient, parent, or guardian that the United States 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. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at (www.//vaers.hhs.gov/).

Manuf. and 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

The trademarks depicted herein are owned by their respective companies.

Copyright ©1996-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-v251-i-2010r019

Patient InformationVAQTA® (pronounced “vac-ta”)(Hepatitis A Vaccine, Purified Inactivated)
This is a summary of information about VAQTA®. Read this information carefully before you or your child receives each dose of VAQTA. If you have any questions about VAQTA after reading this leaflet, you should ask your doctor. This information does not take the place of talking about VAQTA with your doctor or healthcare provider.
What is VAQTA?
  • VAQTA is a vaccine that helps prevent Hepatitis A. Hepatitis A is an infection of the liver.
  • It is a vaccine for people 12 months of age and older.
What do you need to know about VAQTA?
  • You cannot get Hepatitis A from VAQTA.
  • VAQTA will not prevent other types of Hepatitis, such as Hepatitis B.
  • VAQTA may not be effective in everyone who gets the shot.
  • VAQTA is not a treatment for those who already have Hepatitis A.
Who should not get VAQTA?
Do not get VAQTA if you or your child:
  • have had an allergic reaction to any ingredients of VAQTA, including neomycin. (See section titled “What is in VAQTA?” at the end of this leaflet.)
  • have had an allergic reaction to a previous dose of any Hepatitis A vaccine.
What should you tell the doctor or healthcare provider before getting VAQTA?
Tell your doctor or healthcare provider if you or your child:
  • are allergic to latex. The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber. Latex may cause severe allergic reactions in some people.
  • are pregnant or planning to get pregnant.
  • are breast-feeding.
  • have immune problems, like HIV or cancer.
If you have already gotten a Hepatitis A shot, talk to your doctor or healthcare provider to see if VAQTA is right for you.
The doctor will help decide if you or your child should get the shot.
What are the possible side effects of VAQTA?
The most common side effects seen with VAQTA are:
  • pain, soreness, redness, swelling, and warmth where you or your child got the shot
  • headache (adults 19 years and older)
  • fever (children 12 to 23 months)
If you or your child have any of the following problems, tell your doctor right away because these may be signs of an allergic reaction:
  • trouble breathing
  • wheezing
  • hives
  • rash
If you or your child has any side effects that worry you or seem to get worse, tell your doctor or healthcare provider right away.
There may be other side effects that are not listed. For more information, ask your doctor or healthcare provider.
You may report any side effects to your or your child’s doctor or directly to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov, or to Merck Sharp and Dohme Corp, a subsidiary of Merck and Co., Inc. at 1-877-888-4231.

How is VAQTA given?

  • It is a shot given in the arm or thigh.
  • VAQTA is given in two doses on two different dates.
    • the 1st shot is given any time after 12 months of age.
    • the 2nd shot is given 6-18 months after the first shot.
  • If you miss the 2nd shot or if you get your 2nd shot too soon, talk to your doctor or healthcare provider. They will decide what to do.
  • How much VAQTA is given?
    • Children/Adolescents — 12 months through 18 years of age (0.5 mL dose)
    • Adults -19 years of age and older (1.0 mL dose)

What is in VAQTA?

Active ingredient: Hepatitis A virus, Inactivated.

Other ingredients: Aluminum hydroxyphosphate sulphate, sodium borate, sodium chloride, water.

This vaccine contains a trace amount of neomycin.
The vial stopper, syringe plunger stopper and tip cap contain natural latex rubber.
VAQTA does not have any preservatives in it.
For more information, ask your doctor or healthcare provider. Keep this information in case you have questions later.

Manuf. and 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 © 2006-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

crt-usppi-v251-i-2010r000

This Patient Information has been approved by the U.S. Food and Drug Administration.

Issued: 10/2020

PRINCIPAL DISPLAY PANEL — 0.5 mL Vials Carton

NDC 0006-4831-41
10 Single-dose ~25U/0.5-mL Vials

[HEPATITIS A VACCINE, INACTIVATED]
VAQTA®
PEDIATRIC/ADOLESCENT

0.5 mL vial contains approximately 25U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringes Carton

NDC 0006-4095-02 10 Single-Dose 0.5-mL Syringes

[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA®

PEDIATRIC/ADOLESCENT
FORMULATION

This package contains 10 single-dose syringes.
Each 0.5-mL syringe contains approximately 25U of hepatitis A virus antigen on an amorphous aluminum hydroxyphosphate sulfate adjuvant.

Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Vials Carton

NDC 0006-4841-41
10 Single-dose
~50U/1-mL Vials

[HEPATITIS A VACCINE, INACTIVATED]
VAQTA®
ADULT FORMULATION

1 mL vial contains approximately 50U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL -- 1 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Syringes Carton

NDC 0006-4096-02 10 Single-Dose 1-mL Syringes

[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA®

ADULT FORMULATION

This package contains 10 single-dose syringes.
Each 1-mL syringe contains approximately 50U of hepatitis A virus antigen on an amorphous aluminum hydroxyphosphate sulfate adjuvant.

Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.

Rx only

PRINCIPAL DISPLAY PANEL -- 1 mL Syringe Carton
(click image for full-size original)
VAQTA hepatitis a vaccine, inactivated injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4831
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)) HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE 35 ug in 0.5 mL
SODIUM CHLORIDE
WATER
Product Characteristics
Color WHITE (slightly opaque, white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4831-41 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4831-01)
1 NDC:0006-4831-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4831-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103606 03/29/1996
VAQTA hepatitis a vaccine, inactivated injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4095
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)) HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE 35 ug in 0.5 mL
SODIUM CHLORIDE
WATER
Product Characteristics
Color WHITE (slightly opaque, white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4095-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0006-4095-01)
1 NDC:0006-4095-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0006-4095-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103606 03/29/1996
VAQTA hepatitis a vaccine, inactivated injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4841
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)) HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE 70 ug in 1 mL
SODIUM CHLORIDE
WATER
Product Characteristics
Color WHITE (slightly opaque, white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4841-41 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4841-01)
1 NDC:0006-4841-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4841-41)
2 NDC:0006-4841-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4841-01)
2 NDC:0006-4841-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4841-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103606 03/29/1996
VAQTA hepatitis a vaccine, inactivated injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4096
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED)) HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE 70 ug in 1 mL
SODIUM CHLORIDE
WATER
Product Characteristics
Color WHITE (slightly opaque, white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4096-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0006-4096-01)
1 NDC:0006-4096-01 1 mL in 1 SYRINGE This package is contained within the CARTON (0006-4096-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103606 03/29/1996
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 10/2020 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 © 2020. All Rights Reserved.