TWINRIX VACCINE

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

INJECTION

**Dosage and Administration** _Dosage_ A dose of 1.0 ml **Twinrix** is recommended for adults and children aged from 1 year upwards. _Primary vaccination schedule_ - _Adults and adolescents of 16 years of age and above_ The standard primary course of vaccination with **Twinrix** consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose. In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 months schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose. - _Children and adolescents of 1 to 15 years of age_ The standard primary course of vaccination with **Twinrix** consists of two doses, the first is administered at the elected date and the second between six and twelve months after the first dose. Protection against hepatitis B infections may not be obtained until after the second dose. Therefore, **Twinrix** should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course. It is recommended that **Twinrix** should be administered in settings where completion of the 2-dose vaccination course can be assured. The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine. _Booster dose_ Long-term antibody persistence data following vaccination with **Twinrix** in adults and adolescents (0, 1, 6 months) are available up to 20 years after vaccination. Long-term antibody persistence data following vaccination with **Twinrix** (0, 6 months) are available up to 10 years in individuals aged 1–11 years at primary vaccination and up to 15 years in individuals aged 12–15 years at primary vaccination (see section _Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. - _Hepatitis B_ The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected. For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients), a precautionary attitude should be considered to ensure a protective antibody level ≥ 10 international units/l. - _Hepatitis A_ It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses, as protection in the absence of detectable antibodies may be ensured by immunological memory. Guidelines for boosting are based on the assumption that antibodies are required for protection. In situations where a booster dose of both hepatitis A and hepatitis B are desired, **Twinrix** can be given. Alternatively, subjects primed with **Twinrix** may be administered a booster dose of either of the monovalent vaccines. _Method of administration_ **Twinrix** should be injected intramuscularly into the deltoid region of the upper arm in adults and older children. The anterolateral thigh may be used in infants. Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided. Exceptionally, **Twinrix** can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects. However, this route of administration may result in suboptimal immune response to the vaccine.