Rx Item-Havrix HEP A W-O NDL1440 Hepatitis A Hep A Ml Syringe 10X1Ml By Glaxos

Clinical Information
Gen. Code and Des.
62760 hepatitis A virus vaccine/PF INTRAMUSC SYRINGE 1440/ML
GCN and Des.
98534 hepatitis A virus vaccine/PF INTRAMUSC SYRINGE 1440/ML
Strength
1440U
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
3980 hepatitis A virus vaccine
9870 preservative free
Inactive Ingredients
2551 polysorbates 9005645
8921 latex

HAVRIX- hepatitis a virus strain hm175 antigen (formaldehyde inactivated) injection, suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

HAVRIX� is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons aged 12 months and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 Recommended Dose and Schedule
Children and Adolescents

Primary immunization for children and adolescents (aged 12 months through 18 years) 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.

3 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. [See How Supplied/Storage and Handling (16).]
4 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, is a contraindication to administration of HAVRIX [see Description (11)].

RX ITEM-Havrix W-O 1440 Hepatitis A Hep
Item No.:RX127980 NDC No.58160082652 58160-826-52 5816082652 UPC No.:358160826528 NDC No. 58160-0826-52 UPC/GTIN No. 3-58160-82652-8 358160826528 358160-826528 MPN 82652

Havrix W-O 1440 Hepatitis A Hep A Ml Syr
BRAND: HAVRIX NDC: 58160-0826-52,58160082652 UPC: 3-58160-82652-8,358160826528 Glaxosmithkline/Vaccines

HEPATITIS A VIRUS VACCINE
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