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Ambirix product overview

Ambirix indication

Ambirix is a vaccine used for immunisation against hepatitis A virus and hepatitis B virus infection in non-immune children and adolescents from one year up to and including 15 years of age.

Ambirix is a suspension for injection, containing hepatitis A virus (inactivated) (720 ELISA Units) and hepatitis B surface antigen (adsorbed) (20 micrograms).

Ambirix administration

Two doses of Ambirix (each 1.0ml) should be administered intramuscularly, the first administered at the elected date and the second between six and twelve months after the first dose.

Ambirix is for intramuscular injection, usually into the deltoid muscle. However the anterolateral thigh may be used in very young subjects if preferred. Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. However, this route of administration may result in suboptimal immune response to the vaccine.

AMBIRIX SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.

Ambirix efficacy

Ambirix confers immunity against hepatitis A virus (HAV) and hepatitis B virus (HBV) infection by inducing specific anti-HAV and anti-HBs antibodies.

In clinical studies involving subjects from one year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7). Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7). The anti-HBs seroprotection rates (titres ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively

Booster dose

The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines. General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines

Contraindications of Ambirix

Use of Ambirix is contraindicated in patients hypersensitive to the active substances or any of the excipients, hypersensitive to neomycin or hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines. As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.

Adverse reactions for Ambirix

Very common:

  • headache
  • appetite loss
  • irritability
  • fatigue
  • pain and redness at the injection site

Common:

  • drowsiness
  • malaise
  • gastrointestinal symptoms
  • swelling at injection site
  • fever

For further information on Ambirix please see the Ambirix Summary of Product Characteristics.[1]


References:

  1. Ambirix Summary of Product Characteristics

Ambirix is a registered trademark of the GlaxoSmithKline Group of Companies