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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Discard if it appears otherwise. Havrix may be given concurrently with pneumococcal 7-valent conjugate vaccine Wyeth Pharmaceuticals Inc. Efficacy of Havrix for outbreak control The efficacy of Havrix was evaluated in different community outbreaks. Posology Adults 16 years and over Primary immunisation consists of a single dose given intramuscularly.
Agammaglobulinemia, human immunodeficiency virus Paciage infection, hypogammaglobulinemia, immunosuppression, neoplastic disease, radiation therapy, severe combined immunodeficiency SCID. In adults, the injection should be given in the deltoid region.
Stimulation of specific packagee takes place without producing any disease symptoms. Use caution when administering the vaccine to patients with severely compromised cardiopulmonary status.
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.
Havrix should be given to a pregnant woman only if clearly needed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This suspension is purified through ultrafiltration and gel permeation chromatography procedures.
Havrix Monodose Vaccine
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.
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. After removal of the cell culture medium, the cells are lysed to form a suspension. Anaphylaxis Allergic reactions including anaphylactoid reactions and mimicking serum sickness. Administer a booster dose at least 6 months after the first dose to complete the series.
If either of these conditions exists, the vaccine should not be administered. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites.
For most healthy persons, adequate protection is afforded from 1 dose.
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In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Inject into the deltoid muscle of the upper arm.
In outbreak investigations occurring in the packzge, 26 clinical cases of hepatitis A of a total of 34 occurring in the trial occurred.
The vaccine should never be administered intravenously. The response to this booster dose is vigorous and increases the protection time against hepatitis A. In clinical trials, virtually all vaccinees were seropositive one month after the booster dose.
Musculoskeletal and Connective Tissue Disorders: Animal reproduction studies have not been conducted with Havrix. 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.
Solicited local adverse events were reported as follows among children who received the first dose of Havrix coadministered with pneumococcal 7-valent conjugate vaccine: Date of revision of the text.
This response lasts for several months, but during convalescence antibodies of the IgG class become dominant. The presence of antibodies to HAV confers protection against hepatitis A infection.
It is not known whether Havrix is excreted in human milk. The relationship between these data and the duration of protective immunity is unknown. Immunogenicity of Havrix was studied in subjects with chronic liver disease of various etiologies.
When concomitant administration is considered necessary the vaccines must be given at different injection sites.
Havrix – FDA prescribing information, side effects and uses
Increasing the dose of viral antigen directly affects the speed at which seroconversion occurs. Available for Android and iOS devices.
Persistence of the immune response In order to ensure long term protection, a booster dose should packxge given between 6 and 12 months after the primary dose. Pharyngitis, upper respiratory tract infections. Incorrect administration may result in inadequate immunity. Storage of unopened vials: Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy e.