PRODUCT MONOGRAPH. HAVRIX hepatitis A vaccine, inactivated. Suspension This leaflet is part III of a three-part “Product Monograph”. HAVRIX, hepatitis A vaccine, is a sterile suspension containing formaldehyde – has resulted from the administration of any vaccine product. Havrix (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine .. NDC Package of 1 Prefilled Disposable Tip-Lokâ Syringe.

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Hepatitis A virus inactivated 1,2.

Aspirate prior to injection to avoid injection into a blood vessel. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants and young children or the deltoid muscle of the upper arm in older children. One month after the first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults.

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Persistence of the immune response In order to ensure long term protection, a booster dose should be given between 6 and 12 months after the primary dose. Administer a booster dose at least 6 months after the first dose to complete the series. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. Do not mix with any other vaccine or immune globulin. Animal studies are insufficient with respect to reproductive toxicity.

According to imsert guidelines for the prevention and treatment of opportunistic infections in HIV-infected adolescents and adults, assess the IgG antibody response to the hepatitis A vaccine, inactivated one month inaert vaccination, and revaccinate nonresponders.

Primary immunization should be administered at least 2 haveix prior to expected exposure to HAV. Other sources suggest that Havrix GlaxoSmithKline may maintain stability for up to 3 weeks at 37 degrees C.


Fertility No fertility data are available. Havric, erythema multiforme, hyperhidrosis. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Stimulation of specific antibodies takes place without producing any disease symptoms. For most healthy persons, adequate protection is afforded from 1 dose. However, a primary response to the vaccine can be expected 8—10 days after administration.

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for Havrix since market introduction of this vaccine are listed below. Incorrect administration may result in inadequate immunity.

Immunocompromised persons may have a diminished immune response to Havrix, including individuals receiving immunosuppressant therapy.

Havrix Monodose Vaccine

Each 1 mL of vaccine contains EL. There are limited amount of data from the use of this vaccine in pregnant women. Steps should be taken to avoid the risk of bleeding and hematoma formation following intramuscular administration. Musculoskeletal and connective tissue disorders.

Havrix – FDA prescribing information, side effects and uses

It is not known whether Havrix Monodose will prevent hepatitis A in such cases. Posology Adults 16 years and over Primary immunisation consists of a single dose given intramuscularly.

Frequencies per dose are defined as follows: Rapid seroconversion from a single-dose can provide protection against hepatitis A for at least 12 months. Educate the responsible adult s to promptly report any adverse reaction after vaccine administration to a health care provider.

Date of revision of the text. Because changes in vaccine formulation can affect stability and effectiveness, confirmation of acceptable duration havgix storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver.

Havrix has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility. This response lasts for several months, but during convalescence antibodies of the IgG class become dominant. Since virus shedding from pacoage persons may packge for a prolonged period, active immunisation of close contacts may be considered. If needed, administer a booster dose at least 6 months after the first dose to complete the series. Group 1 Havrix coadministered with pneumococcal 7-valent conjugate vaccine Wyeth Pharmaceuticals Inc.


Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks.

Discard the vaccine if the content appears otherwise. The vaccine should be used as supplied; no dilution or reconstitution is necessary. The percentages of subjects for whom solicited local symptoms at the Havrix injection site were reported after the first dose of Havrix in the Havrix alone group compared to subjects who received Havrix coadministered with INFANRIX and Hib conjugate vaccine were as follows: A reduction in the incidence of hepatitis A was observed in countries where a two-dose Havrix immunization programme was implemented for children in their second year of life:.

Patients with chronic hepatic disease may have a lower antibody response to hepatitis A vaccine, inactivated.

Using available testing, these illnesses could neither be proven nor disproven to have been caused by HAV. Also, more severe manifestations of hepatitis A may occur in older patients. In adults, the injection should be given in the deltoid region. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization.