- Approval Id
- 4a2bd2f9dc9b714f
- Drug Name
- TWINRIX VACCINE
- Product Name
- TWINRIX VACCINE
- Approval Number
- SIN10932P
- Approval Date
- 1999-05-18
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong><br>
<u><em>Dosage</em></u><br>
A dose of 1.0 ml <strong>Twinrix</strong> is recommended for adults and children aged from 1 year upwards.</p>
<p><u><em>Primary vaccination schedule</em></u></p>
<ul>
<li><p><em>Adults and adolescents of 16 years of age and above</em><br>
The standard primary course of vaccination with <strong>Twinrix</strong> 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.<br>
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.</p></li>
<li><p><em>Children and adolescents of 1 to 15 years of age</em><br>
The standard primary course of vaccination with <strong>Twinrix</strong> 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, <strong>Twinrix</strong> should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course. It is recommended that <strong>Twinrix</strong> should be administered in settings where completion of the 2-dose vaccination course can be assured.<br>
The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.</p>
<p><u><em>Booster dose</em></u><br>
Long-term antibody persistence data following vaccination with <strong>Twinrix</strong> in adults and adolescents (0, 1, 6 months) are available up to 20 years after vaccination.<br>
Long-term antibody persistence data following vaccination with <strong>Twinrix</strong> (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 <em>Pharmacodynamics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
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.</p></li>
<li><p><em>Hepatitis B</em><br>
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.<br>
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.</p></li>
<li><p><em>Hepatitis A</em><br>
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.<br>
In situations where a booster dose of both hepatitis A and hepatitis B are desired, <strong>Twinrix</strong> can be given. Alternatively, subjects primed with <strong>Twinrix</strong> may be administered a booster dose of either of the monovalent vaccines.</p></li>
</ul>
<p><em><u>Method of administration</u></em><br>
<strong>Twinrix</strong> 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.<br>
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, <strong>Twinrix</strong> 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.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong><br>
<strong>Twinrix</strong> is indicated for use in non-immune adults and children aged from 1 year upwards, who are at risk of both hepatitis A and hepatitis B infection.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
<strong>Twinrix</strong> should not be administered to subjects with known hypersensitivity to any constituent of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of <strong>Twinrix</strong> or the monovalent hepatitis A or hepatitis B vaccines. As with other vaccines, the administration of <strong>Twinrix</strong> should be postponed in subjects suffering from acute severe febrile illness.<br>
<strong>Twinrix</strong> contains traces of neomycin. The vaccine should not be used in subjects with known hypersensitivity to neomycin.</p>
- Atc Code
- J07BC20
- Atc Item Name
- combinations
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
