| Product Information |
|
| Registration Number |
BR-1423
|
| Generic Name |
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B
(IDNA) and Haemophilus influenzae Type B Conjugate
Vaccine (Adsorbed)
|
| Brand Name |
Shan 5
|
| Dosage Strength |
Formulation: Each dose (0.5 mL) contains: Diphtheria toxoid-> 30 IU Tetanus toxoid- > 60 IU Bordetella pertussis (Whole Cell)-> 4U Hepatitis B (r-DNA) surface antigen-10 ug Purified capsular polysaccharide of Hib conjugated to 20-40 mcg Tetanus toxoid (carrier protein)-10 ug
|
| Dosage Form |
Suspension For Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Vaccines
|
| Packaging |
Single dose. 0.5 mL in USP Type I clear glass vial with bromobutyl rubber stopper, aluminum seal with pink flip-off cap, and Vaccine Vial Monitor (VVM) [Box of l's, 10's and 35's]
|
| Manufacturer |
Sanofi Healthcare India Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Sanofi Pasteur, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
07 October 2022
|
| Expiry Date |
07 October 2027
|