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 |
Vaccines
|
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
|