| Product Information |
|
| Registration Number |
BR-919
|
| Generic Name |
Diphtheria, Tetanus, Pertussis (Acellular Component), Hepatitis B, Poliomyelitis (Inactivated) and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
|
| Brand Name |
Hexaxim
|
| Dosage Strength |
Formulation:
Each dose (0.5 mL) contains: Diphtheria toxoid'
Tetanus toxoid '
Bordetella pertussis antigen
Pertussis toxoid'
Filamentous hemagglutinin' Poliovirus (Inactivated)2.3 Type I (Mahoney) strain
NLT 20 IU NLT 40 IU
Hepatitis B surface antigen Haemophilus influenzae Type B
Polysaccharide Phosphate)
10 mcg
(Polyribosylribitol 12 mcg
Conjugate to Tetanus protein
22-36 mcg
25 mcg
25 mcg
40 D antigen units
Type II (MEF-1) strain"
Type III (Saukett) strain1
8 D antigen units
32 D antigen units
'adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
3adsorbed on aluminium phosphate (AIPO4)
*propagated in VERO cells
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Vaccines
|
| Packaging |
0.5 mL in 1 mL pre-filled glass syringe with 2 separate needles (Box of 1's). Single dose.
|
| Manufacturer |
Sanofi Pasteur
|
| Country of Origin |
France
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Renewal
|
| Issuance Date |
04 September 2023
|
| Expiry Date |
29 August 2028
|