- Approval Id
- fc439eb80dafcb43
- Drug Name
- HIBERIX VACCINE 10 MCG/0.5 ML
- Product Name
- HIBERIX VACCINE 10 MCG/0.5 ML
- Approval Number
- SIN09859P
- Approval Date
- 1998-07-02
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Posology</strong></p>
<p>The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 6 weeks.</p>
<p>To ensure a long term protection, a booster dose is recommended in the second year of life.</p>
<p>Infants between the ages of 6 and 12 months previously unvaccinated should receive 2 injections, given with an interval of one month, followed by a booster in the second year of life. Previously unvaccinated children aged 1–5 years should be given one dose of vaccine.</p>
<p>As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations.</p>
<p><strong>Method of Administration</strong></p>
<p>The reconstituted vaccine is for <strong>intramuscular</strong> injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><em><strong>Hiberix</strong></em> is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib.</p>
<p><em><strong>Hiberix</strong></em> does not protect against disease due to other types of <em>H. influenzae</em> nor against meningitis caused by other organisms.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em><strong>Hiberix</strong></em> should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of Hib vaccines.</p>
- Atc Code
- J07AG01
- Atc Item Name
- haemophilus influenzae B, purified antigen conjugated
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD