Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**Dosage and Administration** **Posology** The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 6 weeks. To ensure a long term protection, a booster dose is recommended in the second year of life. 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. As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations. **Method of Administration** The reconstituted vaccine is for **intramuscular** injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously.
INTRAMUSCULAR
Medical Information
**Indications** _**Hiberix**_ is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib. _**Hiberix**_ does not protect against disease due to other types of _H. influenzae_ nor against meningitis caused by other organisms.
**Contraindications** _**Hiberix**_ 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.
J07AG01
haemophilus influenzae B, purified antigen conjugated
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals
Catalent Belgium S.A. (Diluent in pre-filled syringe)
GlaxoSmithKline Biologicals S.A.
GlaxoSmithKline Biologicals S.A. (diluent)
Active Ingredients
PURIFIED CAPSULAR POLYSACCHARIDE OF HIB
10mcg/0.5ml
Documents
Package Inserts
Hiberix Vaccine PI.pdf
Approved: September 12, 2019