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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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Immunization against hepatitis A virus in persons at risk; products utilize inactivated whole virus propagated in MRC5 human diploid cells.

After the first dose, the ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Catch-up vaccination may occur in patients 2 years and older, packaye doses separated by 6 to 18 months. Immune globulin is preferred, although 1 mL IM of the vaccine may be used if immune globulin cannot be obtained. If needed, administer the second vaccine dose 1 mL IM at a later time to complete the series.

The efficacy of the vaccine for postexposure prophylaxis is unknown in patients older than 40 years.

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

Also, more severe manifestations of hepatitis A may occur in older patients. Efficacy when administered greater than 2 weeks after exposure is not established. If needed, administer a booster dose at least 6 months after the first dose to complete the series.

The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 inserr.

Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, and anyone who cannot get the vaccine because of contraindications. Efficacy when administered more than 2 weeks after exposure is not established. Administer a booster dose at least 6 months after the first dose to complete paclage series. For most healthy persons, adequate protection is afforded from 1 dose.

A booster dose can be given at least 6 months after the first dose to complete the series. Adults at least 40 years, immunosuppressed patients, or those with chronic liver disease planning to depart in 2 weeks or less should receive an initial dose of the vaccine plus immune globulin 0. For long-term protection, administer a 0.

Immunosuppressed patients or those with chronic liver disease planning to depart in less than 2 weeks should receive an initial dose of the vaccine plus immune globulin 0.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Inform the patient, parent, guardian, or responsible adult of the benefits and risks pakage the vaccine.

Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization.

As of July 1,health care providers who administer any hepatitis A vaccine to a child or adult must provide copies of the vaccine information statement developed by the Centers for Disease Control and Prevention. Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients.

The health care professional should have immediate availability of epinephrine 1: If a prior hepatitis A vaccine dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.

Inactivated hepatitis A vaccine is administered intramuscularly; do not inject intravenously, intradermally, or subcutaneously. Visually inspect parenteral products for particulate matter and discoloration prior to administration.

After agitation, the injection should appear as an opaque, white, homogenous suspension. Discard if it appears otherwise. The vaccine should be used as supplied; no dilution or reconstitution is necessary. Shake vigorously just prior to administration. With through agitation, Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly opaque, white suspension. If the vaccine cannot be resuspended or the appearance is not as described, discard it.


Do not mix with any other vaccine or nisert globulin. Storage of unopened vials: Store refrigerated at 2—8 degrees C 36 to 46 degrees F ; do not freeze.

According to a published article, storage of Havrix GlaxoSmithKline at room temperature for up to 72 hours is acceptable, and Vaqta Merck can be stored at 37 navrix C Other sources suggest that Havrix GlaxoSmithKline may maintain stability for up to 3 weeks at 37 degrees C.

Because changes in vaccine formulation can affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended. A separate pacjage and needle should be used for each person receiving hepatitis A vaccine, inactivated.

Aspirate prior to injection to avoid injection into a blood vessel. Inject into the deltoid muscle of the upper arm.

Do not inject into the gluteal region as this may result in a suboptimal response. When concomitant administration of other vaccines or immunoglobulin is required, they should be given with different syringes and at different injection sites.

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and knsert the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention CDC website. If a dose of hepatitis A vaccine, inactivated has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration.

Educate the responsible adult s to promptly report any inserf reaction after vaccine administration to a health care provider.

Havrix – FDA prescribing information, side effects and uses

Hepatitis A vaccine, inactivated is contraindicated in patients who have had a severe allergic reaction e. Use of this vaccine is contraindicated in patients with a neomycin hypersensitivity; the vaccines contain a residual amount of neomycin from the manufacturing process. Patients who develop symptoms suggestive of hypersensitivity should not receive further injections of the 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 cause allergic reactions; the plunger and tip caps of Havrix may also contain dry natural latex rubber.

The vial stopper of Havrix does not contain latex. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy e. The vaccine should be given only if the potential benefits clearly outweigh the risk of administration. If the decision is made to administer the vaccine in such persons, the vaccine should be given with caution. Steps should be taken to avoid the risk of bleeding and hematoma formation following intramuscular administration. The decision to administer or to delay vaccination with the hepatitis A vaccine, inactivated because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease.

The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved, unless the patient is at immediate risk of hepatitis A infection. Use caution when administering the vaccine to patients with severely compromised cardiopulmonary status.

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. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness. Patients with immunosuppression may respond to hepatitis A vaccine, inactivated with lower antibody titers than non-immunosuppressed patients. 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.

Patients vaccinated with hepatitis A vaccine, inactivated within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored.


Lower antibody titers are particularly a concern in patients with human immunodeficiency virus HIV infection, as the CD4 count at the time of vaccination has been associated with reduced development of anti-HAV IgG antibodies; however, data suggest that patients will respond to vaccination after immunologic reconstitution with highly active antiretroviral therapy.

In a study, response to vaccination was directly related to the CD4 cell count at vaccination: The relationship between the CD4 count and vaccination response was independent of the nadir CD4 cell count and viral load.

Havrix Monodose Vaccine

According to the guidelines for the prevention and treatment of pavkage infections in HIV-infected adolescents and adults, assess the IgG antibody response to the hepatitis A pwckage, inactivated one month after vaccination, and revaccinate nonresponders. According to the Advisory Committee on Immunization Practices ACIPadministration of inactivated virus vaccines to pregnant women have not resulted in adverse effects in the fetus.

The ACIP recommends vaccination during pregnancy when the likelihood of disease inser is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration of the vaccine to pregnant women only if clearly needed. Data are habrix regarding use of the hepatitis A vaccine, inactivated during breast feeding and its’ excretion in human milk is unknown.

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.

Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse pacmage to the FDA. Hepatitis A vaccine, inactivated is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration.

Incorrect administration may result haveix inadequate immunity. Patients with chronic hepatic disease may have a lower antibody response to hepatitis A vaccine, inactivated. One month after a booster dose given 6 months after dose 1, seroconversion rates were packagr among groups. The relationship between these data and the duration of protective immunity is unknown.

Moderate Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may ibsert with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine.

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 after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. Injection of hepatitis A vaccine produces antibodies that confer protection against hepatitis A infection.

Stimulation of specific antibodies takes place without producing any disease symptoms. During the course of natural infection with the hepatitis A virus, the initial antibody response is predominantly of the IgM class. This response lasts for several months, but during convalescence antibodies of the IgG class become habrix.

The IgG antibodies remain detectable indefinitely. Two years after immunization with hepatitis A vaccine IgG levels remained relatively high in the serum of immunized patients.

The duration of protection from a course of insedt A vaccine is inseft yet unknown. Long term follow-up studies will determine the necessity for booster doses of HAV.