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HAVRIX PACKAGE INSERT PDF

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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Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. One month after the second dose of Isnert, 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.

Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, and anyone who cannot get the vaccine because of contraindications.

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.

Headache common with Havrix Junior Monodose formulation. For long-term protection, administer a 0. Injection of hepatitis A vaccine produces antibodies that confer protection against hepatitis A infection. Solicited local adverse events were reported as follows among children who received the first dose of Havrix coadministered with pneumococcal 7-valent conjugate vaccine: When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites.

Inert administration may result in inadequate immunity. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.

Immune globulin is preferred, although 1 mL IM of the vaccine may be used if immune globulin cannot lackage obtained. The relevance of these data to the duration of protection afforded by Havrix is unknown. In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation. Send the page ” ” to a friend, relative, colleague or yourself.

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Havrix Monodose Vaccine – Summary of Product Characteristics (SmPC) – (eMC)

The efficacy of Havrix ppackage evaluated in different community outbreaks. However, as with all inactivated viral vaccines, the risks to the fetus are considered negligible. The vaccine is particularly indicated for those at increased risk of infection or transmission. When concomitant administration is considered necessary the vaccines must be given at different injection sites.

Havrix Monodose Vaccine

In an open-label, randomized, US multicenter study, children 15 months of age received the 2-dose series of Havrix. Steps should be taken to avoid the risk of bleeding and hematoma formation following intramuscular administration.

Efficacy when administered greater than 2 weeks after exposure is not established. Persons for whom Hepatitis A is an occupational hazard or for whom there is an increased risk of transmission.

This provides anti-HAV antibodies for at least one year. Discard if it appears otherwise. It is not known whether Havrix Monodose will prevent hepatitis A in such cases. Up to 3 additional cases of mild clinical illness may have occurred in vaccinees.

The large trial further allowed for javrix of rare adverse events, including hospitalization and death. The IgG antibodies remain detectable indefinitely. Anaphylaxis Allergic reactions including anaphylactoid reactions and mimicking serum sickness. Storage of unopened vials: Following the booster dose of Havrix, among local reactions: Frequencies per dose are defined as follows: Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

Administer a booster dose at least 6 months after the first dose to complete the series. To bookmark a medicine you must sign up and log in. Havrix Monodose Vaccine may contain traces of neomycin B sulfate, which is used during the manufacturing process see hvarix 4. For example immunisation should be considered for the following risk groups:.

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However, a primary response to the vaccine can be expected 8—10 days after administration. 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. Your email has been sent. In clinical trials, virtually all packagr were seropositive one month after the booster dose. Before use, the vaccine should be well shaken to obtain a slightly opaque white suspension.

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Outbreak Setting and a Field Efficacy Trial: Efficacy of Havrix for outbreak control The efficacy of Havrix was evaluated in different community outbreaks. Immune Response to Havrix EL. The duration of immunity following a complete schedule of immunization with Havrix has not been established. General Disorders and Administration Site Inserf Adults at least 40 years, immunosuppressed patients, or those with chronic liver disease planning to depart in 2 weeks or less should receive an initial dose of the vaccine plus immune globulin 0.

Havrix – FDA prescribing information, side effects and uses

Although a booster should be given within 6 — 12 months of the initial vaccination, it has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels pzckage subjects given a booster within the recommended time period.

This vaccine confers protection against hepatitis A within weeks. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a havric or severe acute febrile illness and administered after the acute phase of illness has resolved, unless the patient is at immediate risk of hepatitis A infection.

Method of administration The vaccine should be injected intramuscularly in the deltoid region. The observed reduction in hepatitis A incidence in the general population vaccinated and non-vaccinated in both countries are consistent with herd immunity.

These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis Indert disease. This site uses cookies. Using additional virological and serological analyses post hoc, the efficacy of Havrix was confirmed.