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-Lok├ó Syringe.

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

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. Depending on the adverse reaction, a pacmage dose may be contraindicated.

Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course see section 5.

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.

Any unused medicinal product or waste material should havrjx disposed of in accordance with local requirements. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

Patients with immunosuppression may respond to hepatitis A vaccine, inactivated with lower antibody titers than non-immunosuppressed patients. The manufacturer recommends administration of the vaccine to pregnant women only if clearly needed.

Breast-feeding It is unknown whether this vaccine is excreted in human milk. No significant differences were found between the cohorts. The other type has a tip cap and a havgix plunger which contain dry natural latex rubber.

Havrix Monodose Vaccine

Further, patients with latex hypersensitivity may not be appropriate candidates for the vaccine as the syringe plunger and tip caps of prefilled syringes and the vial stopper of Vaqta contain dry natural latex rubber that may oackage allergic reactions; the plunger and tip caps of Havrix may also contain dry natural latex rubber.

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Other sources suggest that Havrix GlaxoSmithKline may maintain stability for up to 3 weeks at 37 degrees C.

This vaccine confers protection against hepatitis A within weeks. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

Hypersensitivity to the active substance, to any of the excipients listed in section 6. Use of this vaccine is contraindicated in patients with a neomycin hypersensitivity; the vaccines contain a residual amount of neomycin from the manufacturing process.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: In a clinical study using 2. Medically reviewed on Jan 1, Long term follow-up studies will determine the necessity for booster doses of HAV.

Vaccine response rates were similar among habrix 3 age groups that received Havrix. Two years after immunization with hepatitis A vaccine IgG levels remained relatively high in the serum of immunized patients.

The vial stopper of Havrix does not contain latex. As for all haavrix, appropriate medication e. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months inssert discontinuation of therapy.

Adverse events reported following overdosage were similar to those reported with normal vaccine administration. Shake vigorously just prior to administration. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, and anyone who cannot pacage the vaccine because of contraindications.

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention CDC website.

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Havrix Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine. Discard the vaccine if the content appears otherwise. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks. One month after a booster dose given 6 months after dose 1, seroconversion rates were similar among groups. The safety profile presented below is based on data from more than subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance.

Havrix Monodose Vaccine – Summary of Product Characteristics (SmPC) – (eMC)

Long term persistence of hepatitis A antibody titres has been evaluated following 2 doses of Havrix given 6 to 12 months apart to healthy immunocompetent subjects aged 17 to 40 years. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. Adults 18 years of age, Adolescents, and Children. In a study, response to vaccination was directly related to the CD4 cell count at vaccination: Show table of contents Hide table of contents 1.

We do not record any personal information entered above. 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: Intravenous administration, subcutaneous administration.