Rx Item-Havrix W-O NDL1440U 10X1 ML PFS-KEEP REFRIG- by Glaxo Smith Kline Vaccines

Rx Item-Havrix W-O NDL1440U 10X1 ML PFS-Keep Refrigerated - by Glaxo Smith Kline Vaccines

Rx Item-Havrix W-O NDL1440U 10X1 ML PFS-Keep Refrigerated - by Glaxo Smith Kline Vaccines, Item No. RX127980, 127980, NDC No.: 58160-0826-52, 58160-826-52, 5816082652, 58160082652, 0826-52, 082652 UPC No. 3-58160-82652-8, 358160-826528, 358160826528, Category:RX, Brand Drug Classification: Vaccine-Hepatitis Type A Drug Class: Drug Class: 80120000 Vaccines Brand/generic: Other Names: Hepatitis A Virus Vaccine, Havrix W-O, Havrix W-O, Hepatitis A Virus Vaccine, Havrix W-O

Part Number: RX127980

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Feature: Drug Class: Drug Class: 80120000 Vaccines

Feature: OMP Family:

Feature: Temparature Zone: 30 Refrige./DoNot Freez

Feature: Unit Dose Indicator: NO

Feature 5 Item Size: 10X1ML

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Description
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Clinical Information:Generic Code And Description: 62760 Hepatitis A Virus Vaccine/Pf Preservative Free Intramuscular Syringe 1440/Ml Strength: 1 440 Elisa Unit/MlDose Form: Syringe (Ml) Product Category: Rx Pharmaceuticals Fine Line Class: 850085008510 All Rx Products DEA Class: None Omp Family:Drug Class: 80120000 VaccinesActive Ingredients: 3980 Hepatitis A Virus Vaccine9870 Preservative Free Inactive Ingredients: 8921 Latex

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) injectable suspension, for intramuscular use
Initial U.S. Approval: 1995

INDICATIONS AND USAGE

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 and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. (1)

DOSAGE AND ADMINISTRATION

•: HAVRIX is administered by intramuscular injection. (2.2)
•: Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose administered between 6 to 12 months later. (2.3)
•: Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later. (2.3)

DOSAGE FORMS AND STRENGTHS

•: Suspension for injection available in the following presentations:
•: 0.5-mL single-dose prefilled syringes. (3)
•: 1-mL single-dose prefilled syringes. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin. (4)

WARNINGS AND PRECAUTIONS

•: The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.1)
•: Syncope (fainting) can occur in association with administration of injectable vaccines, including HAVRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.2)

ADVERSE REACTIONS

•: In studies of adults and children 2 years of age and older, the most common solicited adverse reactions 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 reactions 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.

DRUG INTERACTIONS

Do not mix HAVRIX with any other vaccine or product in the same syringe. (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2022

Rx Item-Havrix W-O NDL1440U 10X1 ML PFS-Keep Refrigerated - by Glaxo Smith Kline Vaccines

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