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HSA Approval

HIBERIX VACCINE 10 mcg/0.5 ml

SIN09859P

HIBERIX VACCINE 10 mcg/0.5 ml

HIBERIX VACCINE 10 mcg/0.5 ml

July 2, 1998

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

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HIBERIX VACCINE 10 mcg/0.5 ml - HSA Approval | MedPath