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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Other sources suggest that Havrix GlaxoSmithKline may maintain stability for up to 3 weeks at 37 degrees C. With packzge agitation, Havrix is a homogeneous, turbid, white suspension. Use of this vaccine is inserr in patients with a neomycin hypersensitivity; the vaccines contain a residual amount of neomycin from the manufacturing process.
Immunocompromised persons may have a diminished immune response to Havrix, including individuals receiving immunosuppressant therapy. Subjects with chronic liver disease had a lower antibody response to Havrix than healthy subjects [see Clinical Studies 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.
In a prospective, open-label, multicenter study, 1, children were enrolled into one of 5 groups:. These data are intended packaage guide healthcare professionals in case of temporary temperature excursion only.
However, 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.
Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy e. It is not known whether Havrix is excreted in human milk. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see Contraindications 4 ]. The percentages of subjects for whom solicited local symptoms at the Havrix injection site were reported after the first dose of Havrix in the Havrix alone group compared to subjects who received Havrix coadministered with INFANRIX inserr Hib conjugate vaccine were as follows: Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Havrix has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility. Aspirate prior to injection to avoid injection into a blood vessel.
The efficacy of the vaccine for postexposure prophylaxis is unknown in patients older than 40 years. A similar effect could be observed with Havrix Monodose. Print this page Add to My Med List.
The response to this booster dose havix vigorous and increases the protection time against hepatitis A. Medically pakcage on Jan 1, 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.
To email a medicine you must sign up and log in. Do not dilute to administer. Find out more here. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. 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.
If the vaccine cannot be resuspended or the appearance is not as described, discard it. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. The vial stopper of Havrix does not contain latex. Immune Response to Havrix EL. In subjects with chronic liver disease, local injection site reactions with Havrix were similar ijsert all 4 groups, and no serious adverse events attributed to the vaccine were reported in subjects with chronic liver disease.
Havrix Monodose can be given concomitantly with monovalent and combination vaccines comprised indert measles, mumps, rubella and varicella. In an additional study in which the booster dose was delayed until 1 year following the initial dose, Havrix is available in vials and 2 types of prefilled syringes.
When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Available for Android and iOS devices. Havrix should not be administered in the gluteal region; packwge injections may result in suboptimal response. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
Rapid seroconversion from a single-dose can provide protection against hepatitis A for at least 12 months. 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. The presence of antibodies to HAV confers protection against hepatitis A infection.
Havrix – FDA prescribing information, side effects and uses
The relevance of these data to the duration of protection afforded by Havrix is unknown. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks.
Breast-feeding It packahe unknown whether this vaccine is excreted in human milk.