It is indicated for active immunisation against hepatitis A infection in adults and children 2 years and over. Vaccination against viral hepatitis A is recommended for individuals who are or will be at increased risk of infection: ? travellers to areas of moderate or high endemicity for hepatitis A ? visitors to rural and remote indigenous communities ? child day-care and pre-school personnel ? the intellectually disabled and their carers ? health care providers ? sewerage workers ? men who have sex with men ? injecting drug users ? patients with chronic liver disease ? haemophiliacs who may receive pooled plasma concentrates
The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
The dose is 0.5 mL for each injection. The dose is the same for adults and children. The primary vaccination is performed with one single dose of vaccine. The booster injection can be given 6 to 36 months after the primary vaccination. it may be used as a booster in subjects previously vaccinated with another inactivated hepatitis A vaccine. The combined purified Vi polysaccharide typhoid and inactivated hepatitis A vaccine may be given as a booster injection 6 to 36 months after primary vaccination with it, in subjects over 16 years travelling to areas where hepatitis A and typhoid are endemic. it may be used as a booster injection 6 to 36 months after a primary vaccination performed by the combined purified Vi polysaccharide typhoid and inactivated hepatitis A vaccine to ensure long-term protection against infection with hepatitis A virus. As the vaccine is adsorbed, it must be injected by the intramuscular route in order to minimise local reactions. The recommended injection site is the deltoid region. Do not administer by intradermal or intravenous injection. Ensure that the needle does not enter a blood vessel. The vaccine should not be administered into the buttocks since the varying amount of fatty tissue weaken the immune response. In exceptional circumstances the vaccine may be administered by the subcutaneous route in patients suffering from thrombocytopenia or in patients at risk of haemorrhage. Shake the prefilled syringe before injection to obtain a homogenous suspension. This vaccine must not be mixed with other vaccines in the same syringe. The prefilled syringe is for use in a single patient only and any residue must be discarded.
Known systemic hypersensitivity reaction to any component of it or a lifethreatening reaction after previous administration of this vaccine or a vaccine containing the same substances. Vaccination must be postponed in case of febrile or acute disease.
Nervous system disorders ? Headache Gastrointestinal disorders ? Nausea, diarrhoea, vomiting, abdominal pain Skin and subcutaneous tissue disorder ? Urticaria, rashes associated or not with pruritus Muskuloskeletal and connective tissue disorders ? Arthralgia, myalgia General disorders and administration site condition ? Injection site pain, injection site rash, injection site nodule, pyrexia, asthenia Investigation ? Transaminases increased (mild and reversible)
Use in Pregnancy - Category B2 Use of this vaccine is not recommended during pregnancy. However, as for any inactivated viral vaccine, no secondary effects on embryos and foetuses are to be expected. Animal teratology studies have not been conducted with this vaccine. Use in Lactation It is not known whether this vaccine is excreted in human milk. Caution must be exercised when it is administered to a nursing mother.
Keep out of the reach and sight of children Store and transport at 2°C to 8°C. Protect from light
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