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.

Author: Tygogami Tojasar
Country: Turkmenistan
Language: English (Spanish)
Genre: History
Published (Last): 16 May 2012
Pages: 118
PDF File Size: 18.94 Mb
ePub File Size: 20.77 Mb
ISBN: 397-1-13019-500-9
Downloads: 10271
Price: Free* [*Free Regsitration Required]
Uploader: Faushicage

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

Discard if it appears otherwise. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers although the lowest titer needed to confer protection has not been determined.

Hepatitis A vaccine, inactivated is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Increasing the dose of viral havtix directly affects the speed at which seroconversion occurs. All events were reported as recovered or recovering by the end of the study.

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

Transient increase in liver function tests. 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.

The large pacjage further allowed for analysis of rare adverse events, including hospitalization and death. Havrix Monodose must not be havrox with other vaccines in the same syringe. All subjects were seronegative for hepatitis A antibodies at baseline.

Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy e. In addition to reports in clinical onsert, worldwide voluntary reports of adverse events received for Havrix since market introduction of this vaccine packave listed below. With through agitation, Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly opaque, white suspension. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation.


Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency.

Steps should be taken to avoid the risk of bleeding and hematoma formation following intramuscular administration. Use of these syringes may cause allergic reactions in latex sensitive individuals. Aspirate prior to injection to avoid injection into a blood vessel. It is one of several havrid viruses that cause systemic disease with pathology in the liver. The health care professional should have immediate availability of epinephrine 1: Stimulation of specific antibodies takes place without producing any disease symptoms.

Animal studies are insufficient with respect to reproductive toxicity. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants and young children or the deltoid muscle of the upper arm in older children. Current recommendations pacoage not support the need for psckage booster vaccination among immunocompetent uavrix after a 2-dose vaccination course see section 5. 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.

Because many drugs are excreted in human milk, caution should be exercised when Havrix is administered to a nursing woman.

Havrix – FDA prescribing information, side effects and uses

Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, havvrix anyone who cannot get the vaccine because of contraindications. During the course of natural infection with the hepatitis A virus, the initial antibody response is predominantly of the IgM class.

Hvarix Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required. Storage of unopened vials: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The duration of protection from a course of hepatitis A vaccine is as yet unknown. Amino acid supplement 0.


In addition there may be other groups at risk or specific circumstances such as an outbreak of hepatitis A infection when immunisation should be given. Up to 3 additional cases of mild clinical illness may have occurred in vaccinees. 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 confers immunisation against HAV by stimulating specific immune responses evidenced by the induction of antibodies against HAV.

Discard the vaccine if the havrixx appears otherwise. Inject into the deltoid muscle of the upper arm. 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 ;ackage of the disease. Shake vial or syringe well before withdrawal and use.

This site uses cookies. No studies on the effects of Havrix Monodose on the ability to drive and use machines have been performed. Find out more here.

Long term follow-up studies will determine the necessity for booster doses of HAV. One month after pqckage first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults.

PDR Search

Fertility No fertility data are available. 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. Use caution when administering the vaccine to patients with severely compromised cardiopulmonary status.

Hepatitis A virus has a relatively long incubation period 15 to 50 days. Continue typing to refine.