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Havrix

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Havrix

Indications
Dosage
How Supplied

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.

DOSAGE AND ADMINISTRATION

Preparation For Administration

Shake well before use. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Administration

HAVRIX should be administered by intramuscular injection only. HAVRIX should not be administered in the gluteal region; such injections may result in suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

Recommended Dose And Schedule

Children and Adolescents

Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.

Adults

Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.

HOW SUPPLIED

Dosage Forms And Strengths

Suspension for injection available in the following presentations:

  • 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.
  • 1-mL single-dose vials and prefilled TIP-LOK syringes.

Storage And Handling

HAVRIX is available in single-dose vials and prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation):

720 EL.U./0.5 mL

NDC 58160-825-01 Vial in Package of 10: NDC 58160-825-11
NDC 58160-825-43 Syringe in Package of 10: NDC 58160-825-52

1440 EL.U./mL

NDC 58160-826-01 Vial in Package of 10: NDC 58160-826-11
NDC
58160-826-05 Syringe in Package of 1: NDC 58160-826-34
NDC 58160-826-43 Syringe in Package of 10: NDC 58160-826-52

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.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License No. 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

Last reviewed on RxList: 8/22/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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