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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Last updated on eMC: Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency. To bookmark a medicine you must sign up and log in. Hepatitis A virus has a relatively long incubation period 15 to 50 days. In a study, response to vaccination was directly related to the CD4 cell count at vaccination: Do not mix with any other vaccine or immune globulin.

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

This material is provided for educational purposes only and insertt not intended for medical advice, diagnosis or treatment. Find out more here. Immune Response to Havrix EL. All events were reported as recovered or recovering by the end of the study. To email a medicine you must sign up and log in.

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A booster dose can be given at least 6 months after the first dose to complete the series. Also, Havrix has been found to be efficacious in a clinical study of children at high risk of HAV infection [see Clinical Studies Adults 18 years of age, Adolescents, and Children.

Active ingredient hepatitis a vaccine. When concomitant administration of other vaccines inserh immune globulin is havfix, they should be given with different syringes and at different injection sites. Anaphylactic reaction, anaphylactoid reaction, serum sickness—like syndrome.


Angioedema, erythema multiforme, hyperhidrosis. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Also, more severe manifestations of hepatitis A may occur in older patients.

Animal reproduction studies have not been conducted with Havrix. Because many drugs are excreted in human milk, caution should be exercised when Havrix is administered to a nursing woman. If needed, administer the second vaccine dose 1 mL IM at a later time to complete the series. Injection site reaction, such as swelling or induration uncommon with Havrix Junior Monodose formulation. Havrix has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.

One month after the first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults. Provide the Packagd Information Statements from the manufacturer to the recipient or guardian before each immunization. Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine.

Chills, influenza-like symptoms, injection site reaction, local swelling. Although a booster should be given within 6 — 12 months of the initial vaccination, pacoage has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels to subjects given a booster within the recommended time period.

Date of revision of the text. Following the booster dose of Havrix, among local reactions: Patients who develop symptoms suggestive of hypersensitivity should not receive further injections of the vaccine.

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

Hepatitis A vaccine, inactivated is only pakcage for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Inset table of contents Hide table of contents 1. A decision must be made whether to discontinue breast-feeding or to abstain from vaccination taking into account the benefit of breast feeding for the child and the benefit of vaccination for the woman.


Results of analyses of the co-primary immunogenicity endpoints are as follows: The vial stopper does not contain latex.

Immunocompromised persons may have a diminished immune response to Havrix, including individuals receiving immunosuppressant therapy. Reporting suspected adverse reactions after unsert of the medicinal product is important. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Military and diplomatic personnel. Stimulation of specific antibodies takes place without producing any disease symptoms.

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids used in greater than physiologic dosesmay reduce the immune response to Havrix.

Patients with chronic liver disease including alcoholic cirrhosis, chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cirrhosis.

One type of prefilled ahvrix has a tip cap which may contain natural rubber latex.

Havrix Monodose Vaccine

To maintain the highest antibody titers a booster dose is recommended between 6 and 18 months after the initial dose. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.

In an open-label, randomized, US multicenter study, children 15 months of age received the 2-dose series of Havrix.