| Product Information |
|
| Registration Number |
BR-523
|
| Generic Name |
Diphtheria, Tetanus, Pertussis (Acellular Poliomyelitis (Inactivated) Vaccine and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
|
| Brand Name |
Pentaxim
|
| Dosage Strength |
After reconstitution, each dose (0.5 mL) contains:
Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigen
Pertussis toxoid
Filamentous hemagglutinin Poliovirus (Inactivated)
>30 IU
>40 IU
Polysaccharide influenzae Type B Conjugated to tetanus protein
of
Haemophilus 10 mcg
18-30 mcg
25 mcg
25 mcg
Type I poliomyelitis virus (inactivated)
40 D antigen
units
Type II poliomyelitis virus (inactivated)
8 D antigen units
Type III poliomyelitis virus (inactivated)
32
D' antigen
|
| Dosage Form |
Suspension and Powder for Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I pre-filled glass syringe with 2 separate needles + Type I glass vial (Box of 1's and Box of 10's)
|
| Manufacturer |
Sanofi Pasteur, Inc.
|
| Country of Origin |
France
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Renewal
|
| Issuance Date |
14 September 2023
|
| Expiry Date |
21 August 2028
|