| Product Information |
|
| Registration Number |
DR-XY47922
|
| Generic Name |
Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose
|
| Brand Name |
Dianeal PD-4
|
| Dosage Strength |
Formulation:
Each 100 mL contains:
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
2.5 g 538 mg
448 mg
18.3 mg
5.08 mg
|
| Dosage Form |
Dialysis Solution.
(Intraperitoneal)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Peritoneal Dialytic
|
| Packaging |
2 L and 5 L PVC Twin bag Container in HDPE Overpouch
|
| Manufacturer |
Baxter Manufacturing (Thailand) Co., Ltd.
|
| Country of Origin |
Thailand
|
| Trader |
N/A
|
| Importer |
Vantive, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
08 September 2023
|
| Expiry Date |
24 August 2028
|