HAVRIX PACKAGE INSERT PDF

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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Efficacy of Havrix for outbreak control The efficacy of Havrix was evaluated in different community outbreaks. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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In outbreak investigations occurring in the trial, 26 clinical cases of hepatitis A of a total of 34 occurring in the trial occurred. Persons for whom Hepatitis A is an occupational hazard or for whom there is an increased risk of transmission. With thorough agitation, Havrix is a homogeneous, turbid, white suspension. Efficacy when administered more than 2 weeks after exposure is not established.

Havrix (hepatitis A vaccine) dose, indications, adverse effects, interactions from

Primary immunisation consists of a single dose given intramuscularly. Children had completed a primary series of diphtheria, tetanus, acellular pertussis, and Hib conjugate vaccines.

Related Drug Information Drug Summary. The presence of antibodies to HAV confers protection against hepatitis A infection.

A similar effect could be observed with Havrix Monodose. Do not mix Havrix with any other vaccine or product in the same syringe or vial. Frequencies per dose are defined as follows: Havrix should not be administered in the gluteal region; such injections may result in suboptimal response. No significant differences were found between the cohorts. Shake vial or syringe well before withdrawal and use.

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Healthy Adults 19 to 40 years of age who have not previously received the hepatitis A vaccine and who have been exposed to HAV. Immunosuppressed persons may include patients with human immunodeficiency virus HIV infection; severe combined immunodeficiency SCID ; hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy e.

Havrix Hepatitis A Vaccine is a sterile suspension of inactivated virus for intramuscular administration. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation.

Adverse events reported following overdosage were similar to those reported with normal vaccine administration. Do not mix with any other vaccine or immune globulin. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease.

Outbreak Setting and a Field Efficacy Trial: Continue typing to refine. Solicited local adverse events were reported as follows among children who received the first dose of Havrix coadministered with pneumococcal 7-valent conjugate vaccine: Incorrect administration may result in inadequate immunity. However, some of the effects mentioned under section 4. According to the 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 after vaccination, and revaccinate nonresponders.

Date of revision of the text.

Havrix Monodose Vaccine

Immunocompromised persons may have a diminished immune response to Havrix, including individuals receiving immunosuppressant therapy. Colourless glass vials Type I, Ph Ibsert with grey butyl rubber stoppers and aluminium overcaps fitted with avocado coloured flip-off tops containing 1 ml of suspension in packs of one and The vaccine should never be administered intravenously.

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The relationship between these data and the duration of protective immunity is unknown. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

Store refrigerated at 2—8 degrees C 36 to 46 degrees F ; do not freeze. Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and padkage the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention CDC website. Marketing authorisation number s 9. Amino acid supplement 0. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices ACIPinactivated vaccines pose no risk to breast-feeding mothers or their infants.

It is not known whether Havrix Monodose will prevent hepatitis A in such cases.

If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. These include employees in day care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and paediatric units, pqckage workers and food packagers or handlers.