| Product Information |
|
| Registration Number |
BRP-140
|
| Generic Name |
Diphtheria and Tetanus Vaccine (Adsorbed)
|
| Brand Name |
None
|
| Dosage Strength |
Formulation:
Each dose (0.5 mL) contains:
Diphtheria Toxoid -2 Lf (30 IU)
Tetanus Toxoid -7.5 Lf (40 IU).
Aluminum phosphate*-1.5 mg
Thiomersal*- 0.05 mg
*Aluminum phosphate and Thiomersal, used as an adjuvant and a preservative, respectively.
|
| Dosage Form |
Suspension For Injection (IM)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Vaccines
|
| Packaging |
Single dose. 1 mL (Net content: 0.5 mL) Type I
borosilicate glass ampoule (Box of 10's).
|
| Manufacturer |
PT. Biofarma (Persero)
|
| Country of Origin |
Indonesia
|
| Trader |
|
| Importer |
Maed Pharma Corporation
|
| Distributor |
Maed Pharma Corporation
|
| Application Type |
Initial
|
| Issuance Date |
30 May 2024
|
| Expiry Date |
30 May 2029
|