Avaxim (For child)

• Prevention of Hepatitis A Virus (HAV) Infection:
  Active immunization to prevent hepatitis A infection caused by the hepatitis A virus.
• Travelers to Endemic Areas:
  Recommended for individuals traveling to or residing in regions with intermediate or high hepatitis A endemicity.
• High-Risk Groups:
  Persons with chronic liver disease, men who have sex with men, users of injection and non-injection drugs, laboratory workers exposed to HAV, recipients of clotting factor concentrates, and others at increased risk of HAV infection.
• Outbreak Control:
  Used to control hepatitis A outbreaks in communities, institutions, or other at-risk populations.
• Post-Exposure Prophylaxis (PEP):
  Administered within two weeks of exposure to HAV in individuals aged 12 months and older to prevent onset of infection.

• Adults and Children ≥12 Months:
• Primary Series: Two intramuscular doses of 0.5 mL each, administered 6 to 18 months apart.
• Post-Exposure Prophylaxis:
• Single 0.5 mL intramuscular dose administered as soon as possible, ideally within 14 days of exposure.
• Administration Route:
  Intramuscular injection, preferably into the deltoid muscle.
• Special Populations:
  No dosage adjustments needed for elderly or patients with hepatic or renal impairment. Immunocompromised individuals should receive the standard dosing but may exhibit a reduced immune response.
• Co-administration:
  Can be administered simultaneously with other vaccines at different injection sites without interference.

The inactivated hepatitis A vaccine contains chemically inactivated whole hepatitis A virus particles. Upon intramuscular administration, the vaccine stimulates the immune system to produce specific neutralizing antibodies against HAV. These antibodies bind to the virus, preventing viral entry into hepatocytes and subsequent replication. This immune response confers active immunity, protecting vaccinated individuals from hepatitis A infection.

• Absorption: The vaccine is absorbed locally at the injection site, where antigen-presenting cells process the viral antigen.
• Distribution: The antigen is presented to lymphocytes in local lymph nodes, initiating the immune response.
• Metabolism: The inactivated viral proteins are processed by immune cells; the vaccine itself is not metabolized.
• Excretion: Not applicable, as the vaccine does not contain live virus or active metabolites.
• Onset of Immunity: Protective antibody levels typically develop within 2 to 4 weeks after the first dose.
• Duration of Immunity: Long-lasting immunity is established, generally persisting for at least 20 years following completion of the two-dose series.

• Pregnancy:
  No well-controlled studies in pregnant women are available. Vaccination may be considered during pregnancy if the potential benefits outweigh the risks, especially for women at high risk of HAV exposure.
• Lactation:
  The vaccine is considered safe for use during breastfeeding, as no adverse effects on the infant have been reported. The inactivated virus does not pass into breast milk in clinically significant amounts.

• Primary Class: Viral Vaccine
• Subclass: Inactivated Hepatitis A Vaccine

• Hypersensitivity to any component of the vaccine, including neomycin or aluminum hydroxide.
• History of severe allergic reaction (anaphylaxis) after a prior dose of hepatitis A vaccine.
• Moderate or severe acute illness with or without fever (vaccination should be deferred until recovery).

• Caution in individuals with bleeding disorders or thrombocytopenia to avoid hematoma at the injection site.
• Immunocompromised patients may have a diminished immune response but vaccination is still recommended.
• Not indicated for treatment of active hepatitis A infection.
• Monitor for any signs of allergic reactions post-vaccination; have emergency treatment available.
• No black box warnings are associated with this vaccine.

• Common Adverse Effects:
• Injection site reactions: pain, redness, swelling.
• Systemic symptoms: fatigue, headache, low-grade fever, malaise.
• Uncommon:
• Rash, urticaria.
• Rare:
• Anaphylaxis (extremely rare).
• Very rare reports of neurological adverse events such as Guillain-Barré syndrome; causality not established.

• No clinically significant interactions with other drugs have been identified.
• Immunosuppressive medications may reduce vaccine efficacy.
• Co-administration with other vaccines is generally safe and effective.
• No known interactions with food or alcohol.

• The CDC and WHO recommend routine hepatitis A vaccination for all children aged 12 months and older in endemic areas.
• Post-exposure vaccination remains the preferred method for PEP in healthy individuals aged ≥12 months.
• Booster doses are not routinely required once the primary series is completed.
• Updated surveillance confirms continued vaccine safety and effectiveness.

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Protect from freezing; do not freeze as it may reduce vaccine potency.
• Protect from light exposure.
• Shake well before use.
• Use immediately after opening; discard any unused vaccine according to manufacturer guidelines.