| Product Information |
|
| Registration Number |
BR-1352
|
| Generic Name |
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
|
| Brand Name |
Combe Five
|
| Dosage Strength |
Each dose (0.5 mL) contains: Diphtheria toxoid ................... 25 Lf ( > 30 IU) Tetanus toxoid ...................... 5.5 Lf (> 60 IU) B. pertussis (whole cell) ........... 16 IOU ( >4 IU) Hepatitis B (rDNA) ................ 12.5 ug Purified capsular polysaccharide (PRP) of Hib covalently linked to 20 to 36.7 ug
of tetanus toxoid .... ............... 11 ug Alt+t (as AlPO4) ........ ............. <1.25 mg Thiomersal ............ ........... 0.01% w/v
|
| Dosage Form |
Solution For Injection (I.M)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Multidose: 10 doses. 5 mL USP Type I glass vial with
grey bromobutyl rubber stopper and aluminum flip off seal with vaccine vial monitor (VVM) (Box of 24's) [Net content: 5 mL]
|
| Manufacturer |
Biological E. Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
IP Biotech, Inc.
|
| Distributor |
IP Biotech, Inc.
|
| Application Type |
-
|
| Issuance Date |
08 June 2021
|
| Expiry Date |
08 June 2026
|