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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Havrix Monodose Vaccine may contain traces of neomycin B sulfate, which is used during the manufacturing process see section 4. Active immunisation against infections caused by hepatitis A virus. The vaccine is particularly indicated for those at increased risk of infection or transmission. For example immunisation should be considered for the following risk groups:. Travellers visiting areas of medium or high endemicity, i.
Persons for whom Hepatitis A is an occupational hazard or for whom there is an increased risk of transmission. 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.
Patients with chronic liver disease including alcoholic cirrhosis, chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cirrhosis. Since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts may be considered.
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. Primary immunisation consists of a single dose given intramuscularly.
Havrix Monodose Vaccine
This provides anti-HAV antibodies for at least one year. In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation. Although a booster should be given within 6 packagr 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 to subjects given a booster within the recommended time period.
It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination.
Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course see section 5.
Havrix Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine. In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.
Hypersensitivity to the active substance, to any of the excipients listed in section 6. Immunisation should be postponed in subjects suffering from an acute severed febrile illness.
The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As for all vaccinations, appropriate medication e. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether Havrix Monodose will prevent hepatitis A in such cases. 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.
Syncope fainting can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. A similar effect could be observed with Havrix Monodose.
Havrix Monodose can be given concomitantly with monovalent and hvarix vaccines comprised of measles, mumps, rubella and varicella. When concomitant administration is considered necessary the vaccines must be given at different injection sites.
There are limited amount of data from the use of this vaccine in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity. However, as with all inactivated viral vaccines, the risks to the fetus are considered negligible.
The use of this vaccine may be considered during pregnancy, if necessary. 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. No studies on the effects of Havrix Monodose on the ability to drive and use machines have been performed. However, some of the effects mentioned under section 4.
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. Swelling at the site of injection was the next most frequently reported reactions.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Injection site reaction, such as swelling or induration uncommon with Havrix Junior Monodose formulation. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Cases of overdose have been reported during post-marketing surveillance. Adverse events reported inseert overdosage were similar to those reported with normal vaccine administration. Havrix oackage immunisation against HAV by stimulating specific immune responses evidenced by the induction of antibodies against HAV.
In order to insret long term protection, a booster dose should be given between 6 and 12 months after the primary dose. In clinical trials, virtually all vaccinees were seropositive one month after the booster dose. Long term persistence of hepatitis A antibody titres has been evaluated following 2 doses of Havrix given 6 to 12 months apart to healthy immunocompetent subjects aged 17 to 40 years. Current data do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course.
The efficacy of Havrix was evaluated in different community outbreaks. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks.
A reduction in the incidence of hepatitis A was observed in countries where a two-dose Havrix immunization programme was implemented for children in their second year of life:. The observed reduction in hepatitis A incidence in the general population vaccinated and non-vaccinated in both countries pakcage consistent with herd immunity.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. These data are intended to guide healthcare professionals in case of temporary temperature excursion only. Colourless glass vials Type I, Ph Eur with grey butyl rubber stoppers and aluminium overcaps fitted with avocado coloured flip-off tops containing 1 ml of imsert in packs of one and Inzert use, the vaccine should be well shaken to obtain a slightly opaque white suspension.
Havrix (hepatitis A vaccine) dose, indications, adverse effects, interactions from
Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text.
This information is intended for use by health professionals. For example immunisation should be considered for the following risk groups: Military and diplomatic personnel. Posology Adults 16 years and over Primary immunisation consists of a single dose given intramuscularly. This vaccine confers protection against hepatitis A within weeks. The results described above should be considered to apply only to immunocompetent adults.
Method of administration The vaccine should be injected intramuscularly in the deltoid region. The vaccine should never be administered intravenously. Havrix Monodose must not be mixed with other vaccines in the same syringe. Pregnancy There are limited amount of data from the use of this vaccine in pregnant women. Breast-feeding It is unknown whether this vaccine is excreted in human milk.
Fertility No fertility data are available. Frequencies per dose are defined as follows: 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.
Efficacy of Havrix for outbreak control The efficacy of Havrix was evaluated in different community outbreaks. Impact of mass vaccination on disease incidence A reduction in the incidence of hepatitis A was observed in countries where a two-dose Havrix immunization programme was implemented for children in their second year of life: Polysorbate 20 Amino acids for injection Disodium phosphate Monopotassium phosphate Sodium chloride Potassium chloride Water for injections For adsorbent, see section 2.
Store in the original package in order to protect from light. Not all pack sizes may be marketed.
Havrix – FDA prescribing information, side effects and uses
Date of first authorisation: To bookmark a medicine you must sign up and log in. Sign Up Log In Cancel. To email a medicine haveix must sign up and log in. To view the changes to a medicine you must sign up and log in. Find out more here. Hepatitis A virus inactivated 1,2.