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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Find out more here. In an additional study in which the booster dose was delayed until 1 year following the initial dose, However, some of the effects mentioned under section 4. Discard if it appears otherwise. Educate the responsible adult s to promptly report any adverse reaction after vaccine administration to a health care provider.

With thorough agitation, Havrix is a homogeneous, turbid, white suspension. Qualitative and quantitative composition 3. Military and diplomatic personnel. After removal of the cell culture medium, the cells are lysed to form a suspension.

Immune globulin is preferred, although 1 mL IM of the vaccine may be used if immune globulin cannot be obtained. For primary immunization Havrix or Vaqta. Travellers visiting areas of medium or high endemicity, i. These data are intended to guide healthcare professionals in case of temporary temperature excursion only. Angioneurotic oedema Erythema multiforme Urticaria.

Havrix Monodose Vaccine

Reporting suspected adverse reactions after authorisation of the medicinal product is important. One month after the second dose of Havrix, the GMT in each of the younger age groups 11 to 13 and 15 to 18 months of age was shown to be similar to that achieved in the 23 to 25 months of age group. For example immunisation should be considered for the following risk groups: However, a primary response to the vaccine can be expected 8—10 days after administration.


The IgG antibodies remain detectable indefinitely.

Havrix – FDA prescribing information, side effects and uses

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. Immunisation should be postponed in subjects suffering from an acute severed febrile illness. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids used in greater hhavrix physiologic dosesmay reduce the immune response to Havrix.

Using available testing, these illnesses could neither be proven nor disproven to have been caused by HAV. No studies on the effects of Havrix Monodose on the ability to drive and use machines have been performed.

Intravenous administration, subcutaneous administration. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: If either of these conditions exists, the vaccine should not be administered.

At pacoage time point, geometric mean antibody titers GMTs were lower for subjects with chronic liver disease than for healthy subjects. 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.

Also, report an adverse event to the manufacturer of the specific agent administered. When concomitant administration is considered necessary the vaccines must be given at different injection sites.


Before use, the vaccine should be well shaken to obtain a slightly opaque white suspension. In a prospective, open-label, multicenter study, 1, children were enrolled into one knsert 5 groups:. 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. However, as ahvrix all inactivated viral vaccines, the risks to the fetus are considered negligible.

It is not known whether Havrix Monodose will prevent insdrt A in such cases. Use caution when administering the vaccine to patients with severely compromised cardiopulmonary status.

No cases occurred in vaccinees who received Havrix. Marketing authorisation holder 8. These include employees in day care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and paediatric units, sewage workers and food packagers or handlers.

For most healthy persons, adequate protection is afforded from 1 dose. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months. FDA alerts for all medications. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Send the page ” ” packafe a friend, relative, colleague or yourself.