Hepatitis A vaccine, inactivated

Name: Hepatitis A vaccine, inactivated

Indications

VAQTA® [Hepatitis A Vaccine, Inactivated] is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Warnings

Included as part of the PRECAUTIONS section.

Patient information

Instructions

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).

What is hepatitis a vaccine (havrix, vaqta)?

Hepatitis is a serious disease caused by a virus. Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A adult vaccine is used to help prevent this disease in adults. The vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

Like any vaccine, the hepatitis A vaccine may not provide protection from disease in every person.

Precautions

General

VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognized hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.

As with any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

VAQTA should be administered with caution to people with bleeding disorders who are at risk of hemorrhage following intramuscular injection (see DOSAGE AND ADMINISTRATION ).

As with any vaccine, vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

An acute infection or febrile illness may be reason for delaying use of VAQTA except when, in the opinion of the physician, withholding the vaccine entails a greater risk.

Carcinogenesis, Mutagenesis, Impairment of Fertility

VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a woman who is breast feeding.

Pediatric Use

VAQTA has been shown to be generally well tolerated and highly immunogenic in individuals 2 through 18 years of age. See DOSAGE AND ADMINISTRATION for the recommended dosage schedule.

Safety and effectiveness in infants below 2 years of age have not been established.

Geriatric Use

Of the total number of adults in clinical studies of VAQTA, conducted pre- and post-licensure, 68 were 65 years of age or older, 10 of whom were 75 years of age or older. No overall differences in safety and immunogenicity were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. In a large post-marketing safety study in 42,110 individuals, >/=2 years of age, 4769 were 65 years of age or older, 1073 of whom were 75 years of age or older. There were no adverse experiences judged by the investigator to be vaccine related in the geriatric study population. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

How Supplied

PEDIATRIC/ADOLESCENT FORMULATION

Vials

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, NDC 0006-4831-00.

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, in a box of 5 single-dose vials, NDC 0006-4831-38.

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4831-41.

Syringes

No. 4845--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose prefilled syringe, with a 5/8 needle, NDC 0006-4845-00.

No. 4845--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose prefilled syringe, with a 5/8 inch needle, in a box of 5 single-dose prefilled syringes, with 5/8 inch needles, NDC 0006-4845-38.

ADULT FORMULATION

Vials

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, NDC 0006-4841-00.

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, in a box of 5 single-dose vials, NDC 0006-4841-38.

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4841-41.

Syringes

No. 4844--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled syringe, with a one inch needle, NDC 0006-4844-00.

No. 4844--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled syringe, with a one inch needle, in a box of 5 single-dose, prefilled syringes, with one inch needles, NDC 0006-4844-38.

Storage

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE since freezing destroys potency.

Manuf. and Dist. by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Syringes of VAQTA are also filled by:

Evans Vaccines Ltd.

Gaskill Road, Speke, Liverpool L24 9GR, England

9413406 Issued July 2004

COPYRIGHT © MERCK & CO., Inc., 2001

All rights reserved

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