HAVRIX- hepatitis a vaccine injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ) (HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:5BFC8LZ6LQ)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN - UNII:5BFC8LZ6LQ)

Composition:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see Description (11)] . Pregnancy Category C Animal reproduction studies have not been conducted with HAVRIX. It is also not known whether HAVRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX should be given to a pregnant woman only if clearly needed. It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman. The safety and effectiveness of HAVRIX, doses of 360 EL.U. or 720 E

Product summary:

HAVRIX is available in single-dose vials (contain no latex) and prefilled TIP-LOK syringes (may contain latex) (packaged without needles) (Preservative Free Formulation): 720 EL.U./0.5 mL NDC 58160-825-01 Vial (contains no latex) in Package of 10: NDC 58160-825-11 NDC 58160-825-43 Syringe (tip cap may contain latex) in Package of 10: NDC 58160-825-52 NDC 58160-825-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-825-46 NDC 58160-825-41 Syringe (tip cap and plunger contain latex) in Package of 10: NDC 58160-825-51 1440 EL.U./mL NDC 58160-826-01 Vial (contains no latex) in Package of 10: NDC 58160-826-11 NDC 58160-826-43 Syringe (tip cap may contain latex) in Package of 5: NDC 58160-826-48 NDC 58160-826-43 Syringe (tip cap may contain latex) in Package of 10: NDC 58160-826-52 NDC 58160-826-32 Syringe (tip cap and plunger contain latex) in Package of 1: NDC 58160-826-32 NDC 58160-826-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-826-46 Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not dilute to administer.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HAVRIX - HEPATITIS A VACCINE INJECTION, SUSPENSION
DISPENSING SOLUTIONS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HAVRIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HAVRIX.
HAVRIX (HEPATITIS A VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster
dose administered between 6 to 12 months later.
(2.2)
Adults: A single 1-mL dose and a 1-mL booster dose administered
between 6 to 12 months later. (2.2)
For intramuscular use only. (2.2)
DOSAGE FORMS AND STRENGTHS
Suspension for injection available in the following presentations:
0.5-mL single-dose vials and prefilled syringes. (3)
1-mL single-dose vials and prefilled syringes. (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
In studies of adults and children 2 years of age and older, the most
common solicited adverse events were injection-site
soreness (56% of adults and 21% of children) and headache (14% of
adults and less than 9% of children). (6.1)
In studies of children 11 to 25 months of age, the most frequently
reported solicited local reactions were pain (32%)
and redness (29%). Common solicited general adverse events were
irritability (42%), drowsiness (28%), and loss of
appetite (28%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR VAERS AT 1-
800-822-7967 OR WWW.VAERS.HHS.GOV. (6)
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2011
HAVRIX is a vaccine indicated for active immunization against disease
caused by hepatitis A virus (HAV). HAVRIX is
approved for use in persons 12 months of age or older. Primary
immunization should be administered at least
2 weeks prior to expected exposure to HAV. (1)
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any hepatitis A-containing vaccine, or to any
component