| Product Information |
|
| Registration Number |
BR-1087
|
| 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->30IU Tetanus toxoid->60IU Bordetella pertussis (Whole Cell)-> 4 IU Hepatitis B (r-DNA) surface antigen-10ug Purified capsular polysaccharide of Hib conjugated to
20-40 mcg Tetanus toxoid (carrier protein)-10ug
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Single dose. 0.5 mL USP Type I clear glass vial with
halogenated butyl rubber stopper and aluminum flip-off seal with Vaccine Vial Monitor (VVM) [Box of l's, 10's and 35's]
|
| Pharmacologic Category |
-
|
| Manufacturer |
Shantha Biotechnics Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Sanofi Pasteur, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
07 June 2022
|
| Expiry Date |
05 June 2025
|