Overview
Commonly found in salts with sodium and calcium. Gluconic acid or gluconate is used to maintain the cation-anion balance on electrolyte solutions.
Indication
For use as part of electrolyte supplementation in total parenteral nutrition [FDA Label].
Associated Conditions
- Fluid Loss
- Shock, Hemorrhagic
- Mild Metabolic acidosis
- Moderate Metabolic acidosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-389 | INTRAVENOUS | 502 mg in 100 mL | 6/18/2021 | |
| Terumo BCT Ltd. | 14537-408 | INTRAVENOUS | 0.5 g in 100 mL | 5/8/2015 | |
| ICU Medical Inc. | 0990-6141 | IRRIGATION | 502 mg in 100 mL | 1/6/2022 | |
| ICU Medical Inc. | 0990-7670 | INTRAVENOUS | 502 mg in 100 mL | 1/6/2022 | |
| B. Braun Medical Inc. | 0264-7707 | INTRAVENOUS | 0.5 g in 100 mL | 10/6/2023 | |
| B. Braun Medical Inc. | 0264-7703 | INTRAVENOUS | 0.5 g in 100 mL | 9/17/2018 | |
| Baxter Healthcare Corporation | 0338-0179 | INTRAVENOUS | 502 mg in 100 mL | 8/28/2017 | |
| ICU Medical Inc. | 0990-7968 | INTRAVENOUS | 502 mg in 100 mL | 11/6/2020 | |
| Fresenius Kabi USA, LLC | 65219-387 | INTRAVENOUS | 502 mg in 100 mL | 7/1/2021 | |
| Baxter Healthcare Corporation | 0338-0221 | INTRAVENOUS | 502 mg in 100 mL | 8/28/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PLASMA-LYTE A INJECTION | SIN06523P | INJECTION | 502 mg/100 ml | 8/19/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PLASMA-LYTE 148 AND GLUCOSE 5% W/V SOLUTION FOR INFUSION | N/A | N/A | N/A | 8/23/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PLASMA-LYTE 148 and 5% GLUCOSE 1000mL injection bag AHB2584 | 19438 | Medicine | A | 9/30/1991 | |
| PLASMA-LYTE 148 (approx. pH 7.4) 1000mL injection bag AHB2544 | 231425 | Medicine | A | 12/11/2014 | |
| PLASMA-LYTE 148 (approx. pH 7.4) 500mL injection bag AHB2543 | 231424 | Medicine | A | 12/11/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LYPHOLYTE MULTI-ELECTROLYTE CONC INJ | lyphomed, division of fujisawa canada inc. | 01944940 | Liquid - Intravenous | 55 MG / ML | 12/31/1991 |
| NORMOSOL-R | ICU Medical Canada Inc | 00039500 | Solution - Intravenous | 0.502 G / 100 ML | 12/31/1965 |
| PLASMALYTE 148 IN 5% DEXTROSE INJ | baxter corporation | 00260592 | Solution - Intravenous | 502 MG / 100 ML | 12/31/1958 |
| NORMOSOL-R & 5% DEXTROSE | ICU Medical Canada Inc | 00039640 | Solution - Intravenous | 0.502 G / 100 ML | 12/31/1965 |
| LYPHOLYTE | Pharmaceutical Partners Of Canada Inc | 02139618 | Solution - Intravenous | 1.1 G / 20 ML | 8/14/1996 |
| RENACIDIN | guardian laboratories, division of united-guardian inc. | 00113069 | Powder For Solution - Topical
,
Irrigation | 25 G / 300 G | 12/31/1960 |
| PLASMA-LYTE A INJECTION | baxter corporation | 02339358 | Solution - Intravenous | 502 MG / 100 ML | 12/23/2010 |
| ISOLYTE S WITH 5% DEXTROSE INJ | b. braun medical inc | 01935992 | Solution - Intravenous | 500 MG / 100 ML | 9/10/1996 |
| HYPERLYTE (MULTI-ELECTROLYTE CONCENTRATE) | b. braun medical inc | 01963910 | Liquid - Intravenous | 1.09 G / 25 ML | 9/4/1998 |
| ISOLYTE S PH 7.4 (MULTI-ELECTROLYTE INJECTION) | b. braun medical inc | 01931679 | Solution - Intravenous | 500 MG / 100 ML | 9/10/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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