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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Also, more severe manifestations of hepatitis A may occur in older patients.

No significant differences were found between the cohorts. In order to ensure long term protection, a booster dose should be given between 6 and 12 months after the primary dose. Do not administer if it appears otherwise. Continue typing to refine. Aspirate prior to injection to avoid injection into a blood vessel. When concomitant administration is considered necessary the vaccines must be given at different injection sites.

After agitation, the injection should appear as an opaque, white, homogenous suspension. In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.

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Posology Adults 16 years and over Primary immunisation consists of a single dose given intramuscularly. This provides anti-HAV antibodies for at least one year. Latex hypersensitivity, neomycin hypersensitivity. Do not inject into the gluteal region as this may result in a suboptimal response.

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

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. In an additional study in which the booster dose was delayed until 1 year following the initial dose, Two years after immunization with hepatitis A vaccine IgG levels remained relatively high in the serum of immunized patients. If needed, administer the second vaccine dose 1 mL IM at a later time to complete the series.


The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Intravenous administration, subcutaneous administration.

One month after vaccination, non-inferiority was demonstrated with respect to GMTs for anti-pneumococcal antibodies to all 7 serotypes after the coadministration of pneumococcal 7-valent conjugate vaccine with Havrix compared to pneumococcal 7-valent conjugate vaccine alone. Skin and Subcutaneous Tissue Disorders: The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm.

For long-term protection, administer a 0. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. 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 cause allergic reactions; the plunger and tip caps of Havrix may also contain dry natural latex rubber.

Adults 18 years of age, Adolescents, and Children.

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. Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine.

If either of these conditions exists, the vaccine should not be administered.

Patients who develop symptoms suggestive of hypersensitivity should not receive further injections of the vaccine. Amino acid supplement 0. Children had completed a primary series of diphtheria, tetanus, acellular pertussis, and Hib conjugate vaccines.

The titers obtained from this additional dose approximate hxvrix observed several years after natural infection. Since virus shedding from infected persons may packaye for a prolonged period, active immunisation of close contacts may be considered.

Severe allergic reaction e. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Solicited general adverse events were reported as follows among children who received the first dose of Havrix coadministered with pneumococcal 7-valent conjugate vaccine: To view the changes to a medicine you must sign up and log in. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Patients with chronic liver disease including alcoholic cirrhosis, chronic hepatitis B, chronic onsert C, paxkage hepatitis, primary biliary cirrhosis.


It is not known whether Havrix is excreted in human milk. With through agitation, Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly opaque, white suspension. A separate syringe and needle should be used for each person receiving hepatitis A vaccine, inactivated. Also, Havrix has been found to be efficacious in a clinical study of children haveix high risk of HAV infection [see Clinical Studies Recipient’s Email Separate multiple email address inser a comma Please enter valid email address Recipient’s email is required.

Discard if it appears otherwise.

Havrix – FDA prescribing information, side effects and uses

During the course of natural infection with the hepatitis A virus, the initial antibody response is predominantly of the IgM class. This site uses cookies. In the Havrix group, 2 cases were identified. Using available testing, these illnesses could neither be proven nor disproven to have been caused by HAV.

Pharyngitis, upper respiratory tract infections. These include employees in day care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and paediatric units, sewage workers and food packagers or handlers.

Havrix Monodose Vaccine

Cases of overdose pzckage been reported during post-marketing surveillance. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids used in greater than physiologic dosesmay reduce the immune response to Havrix. Subjects with chronic liver disease had a lower antibody response to Havrix than healthy subjects [see Clinical Studies