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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The second dose of Havrix was given 6 to 9 months after the first dose.
Havrix may be given concurrently with pneumococcal 7-valent conjugate vaccine Wyeth Pharmaceuticals Inc. Anticoagulant therapy, coagulopathy, hemophilia, ineert, vitamin K deficiency.
In a prospective, open-label, multicenter study, 1, children were enrolled into one of 5 groups:. Subscribe to free Drugs. Adults 18 years of age, Adolescents, and Children. The vaccine is particularly indicated for those at increased risk of infection or transmission.
To maintain the highest antibody titers a booster dose is recommended between 6 and 18 months after the initial dose. Lackage vigorously just prior to administration. If needed, administer the second vaccine dose 1 mL IM at a later time to complete the unsert. Because these events are reported voluntarily from a population of uncertain size, packkage is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Animal studies are insufficient with respect to reproductive toxicity. The duration of immunity following a complete schedule of immunization with Havrix has not been established. It is also not known whether Havrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Insegt many drugs are excreted in human milk, caution should be exercised when Havrix is administered to a nursing woman.
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. Havrix should be administered by intramuscular injection only. A separate syringe and needle should be used for each person receiving hepatitis Packgae vaccine, inactivated. Aspirate prior to injection to avoid injection into a blood vessel. A similar effect could be observed with Havrix Monodose. In a clinical study using 2.
The observed reduction in hepatitis A incidence in the general population vaccinated and non-vaccinated in both countries are consistent with herd immunity. Hacrix immunization should be administered at least 2 weeks prior to expected exposure to HAV.
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Injection of hepatitis A vaccine produces antibodies that confer protection against hepatitis A infection. Using additional virological and serological analyses post hoc, the efficacy of Havrix was confirmed. Inform the patient, parent, guardian, or responsible adult hsvrix the benefits and risks of the vaccine.
It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. Discard the vaccine if the content appears otherwise. Current data do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course.
Insret Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible.
These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. 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 may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Latex hypersensitivity, neomycin hypersensitivity.
Because changes bavrix 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.
The GMTs obtained following a single dose of Havrix are at least several times higher than that expected following receipt of immune globulin. Persistence of the immune response In order to ensure long term protection, a booster dose should be given between 6 and 12 months after the primary dose.
In order to ensure long term protection, a booster dose should be given between 6 and 12 months after the primary dose.
Havrix – FDA prescribing information, side effects and uses
Hypersensitivity to the active substance, to any of the excipients listed in section 6. In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after the primary immunisation and such patients may therefore require administration of additional doses of vaccine.
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.
The results described above should be considered to apply only to immunocompetent adults. In this trial, 14 subjects reported 24 serious adverse events, including 6 subjects in the Havrix group status asthmaticus, asthma [2 events], failure to thrive, gastroenteritis, arthritis bacterial, developmental delay, expressive language disorder, dehydration [3 events]3 subjects in the group who received Havrix coadministered with INFANRIX and Hib conjugate vaccine dehydration, gastroenteritis rotavirus, gastroenteritis, pyrexia, tachycardiaand 5 subjects in the group that received the INFANRIX and Hib conjugate vaccine followed by Havrix bronchial hyperreactivity, respiratory distress, developmental delay, expressive language disorder, dehydration [2 events], gastroenteritis rotavirus, tonsillar hypertrophy.
Other sources suggest that Havrix GlaxoSmithKline may maintain stability for up to 3 weeks at 37 degrees C. Havrix has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility. Skin and Subcutaneous Tissue Disorders: With through agitation, Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly opaque, white suspension. However, some of the effects mentioned under section 4.
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.
Havrix Monodose Vaccine
The vaccine should oackage be administered intravenously. 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. The lowest antibody titer needed to confer protection is unknown.
Use of these syringes may cause allergic reactions in latex sensitive individuals. In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary isnert dose human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.