Overview
Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium chloride is the primary salt in seawater and in the extracellular fluid of many multicellular organisms. It is listed on the World Health Organization Model List of Essential Medicines.
Indication
This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.
Associated Conditions
- Allergic Rhinitis (AR)
- Corneal Edema
- Dehydration
- Dehydration Hypertonic
- Fluid Loss
- Hemodilution
- Hypokalemia
- Hyponatremia
- Hypotonic Dehydration
- Hypovolaemia
- Increase in Intracranial Pressure (ICP)
- Increased Intra Ocular Pressure (IOP)
- Inflammation of the Nasal Mucosa
- Isotonic Dehydration
- Metabolic Acidosis
- Nasal Congestion
- Nasal irritation
- Oliguria caused by Acute Renal Failure (ARF)
- Potassium deficiency
- Sinusitis
- Skin Irritation
- Sodium Depletion
- Dryness of the nose
- Hypochloremic state
- Mild Metabolic acidosis
- Mild, moderate Metabolic Acidosis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/06/01 | Phase 4 | Completed | LG Life Sciences | ||
2015/05/01 | Not Applicable | Completed | Region Örebro County | ||
2015/04/20 | Phase 4 | Terminated | Kenneth Taylor, M.D. | ||
2014/01/31 | Not Applicable | Terminated | |||
2014/01/27 | Phase 2 | Terminated | |||
2013/08/13 | Phase 4 | Completed | |||
2013/03/22 | Phase 4 | Completed | University Hospital, Grenoble | ||
2013/02/21 | Phase 4 | Terminated | |||
2012/02/22 | Phase 4 | Suspended | |||
2011/11/02 | Not Applicable | Completed | Hillerod Hospital, Denmark |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-150 | INTRAVENOUS | 2.25 g in 500 mL | 10/25/2022 | |
| IT3 Medical LLC | 70529-023 | INTRAVENOUS | 9 g in 1000 mL | 6/13/2018 | |
| Cardinal Health 107, LLC | 55154-0126 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 9 mg in 1 mL | 2/6/2023 | |
| LABORATORIOS GRIFOLS SA | 76297-001 | INTRAVENOUS | 9 g in 1000 mL | 7/19/2022 | |
| B. Braun Medical Inc. | 0264-7614 | INTRAVENOUS | 0.33 g in 100 mL | 9/21/2022 | |
| B. Braun Medical Inc. | 0264-7750 | INTRAVENOUS | 0.6 g in 100 mL | 9/12/2022 | |
| ICU Medical Inc. | 0990-6138 | IRRIGATION | 900 mg in 100 mL | 10/29/2020 | |
| Strides Pharma Science Limited | 64380-769 | ORAL | 11.2 g in 4 L | 11/9/2022 | |
| Fresenius Kabi USA, LLC | 65219-389 | INTRAVENOUS | 526 mg in 100 mL | 6/18/2021 | |
| B. Braun Medical Inc. | 0264-7612 | INTRAVENOUS | 0.45 g in 100 mL | 9/21/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) 1000mL injection bag | 47410 | Medicine | A | 1/31/1994 | |
| DIANEAL PD-4 Peritoneal Dialysis Solution with 0.55% w/v Glucose Low Calcium Freeline Solo Twin | 51244 | Medicine | A | 3/17/1995 | |
| BAXTER CARDIOPLEGIA SOLUTION A, 1000mL solution bag | 56336 | Medicine | A | 7/10/1996 | |
| Haemofiltration Solution Citrate - 14 mmol/litre | 171995 | Medicine | A | 6/3/2010 | |
| Schuessler Tissue Salts Fluid Balance Nat Mur | 108967 | Medicine | A | 9/16/2004 | |
| Hydralyte Sports Orange Flavoured Effervescent Electrolyte Tablets | 346493 | Medicine | A | 10/23/2020 | |
| Hydralyte Sports Lemon Lime Flavoured Electrolyte Ice Blocks | 343445 | Medicine | A | 9/14/2020 | |
| Hydralyte Orange Electrolyte Solution | 229729 | Medicine | A | 10/24/2014 | |
| Hydralyte Apple Blackcurrant Electrolyte Solution | 229730 | Medicine | A | 10/24/2014 | |
| Chemists' Own Effervescent Electrolyte Tablets Lemon-Lime Flavour | 369798 | Medicine | A | 6/18/2021 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ACID CONCENTRATE 3187 | baxter corporation | 00883549 | Liquid - Haemodialysis | 172.19 G / L | 12/31/1992 |
| ACID CONCENTRATE D12209 | baxter corporation | 00890200 | Liquid - Haemodialysis | 263 G / L | 12/31/1990 |
| INSTILLATION MEDIUM FOR IMMUCYST | aventis pasteur limited | 01974505 | Liquid - Intravesicular | 440 MG / 50 ML | 12/31/1994 |
| PEGLYTE POWDER | pendopharm division of pharmascience inc | 00777838 | Powder For Solution - Oral | 5.85 G / BOTTLE | 12/31/1988 |
| ACID CONCENTRATE D12318 | althin biopharm inc. | 02216507 | Liquid - Haemodialysis | 195.9 G / L | 12/31/1996 |
| ACID CONCENTRATE RZ186C | genpharm ulc | 02178249 | Liquid - Haemodialysis | 263 G / L | 12/31/1995 |
| BICAVERA FORTE 1.5% GLUCOSE | fresenius medical care canada inc | 02269384 | Solution - Haemodialysis | 10.99 G / L | N/A |
| ACID CONCENTRATE RO9500 | genpharm ulc | 00898406 | Liquid - Haemodialysis | 214.8 G / L | 12/31/1990 |
| VERMOPT | terra botanica products ltd. | 02233378 | Liquid - Oral | 12 X | 5/25/1998 |
| SORNIX | terra botanica products ltd. | 02233368 | Liquid - Oral | 30 X | 5/25/1998 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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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