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Isotonic sodium chloride 0.9 percent
Isotonic sodium chloride 0.9% restores and maintains fluid and electrolyte balance by providing a physiologically balanced saline solution that matches blood osmolarity.
Isotonic sodium chloride 0.9% restores and maintains fluid and electrolyte balance by providing a physiologically balanced saline solution that matches blood osmolarity. Used for Fluid and electrolyte replacement in dehydration, Vehicle for intravenous drug administration, Maintenance of vascular access patency.
At a glance
| Generic name | Isotonic sodium chloride 0.9 percent |
|---|---|
| Also known as | Isotonic saline |
| Sponsor | Rigshospitalet, Denmark |
| Drug class | Crystalloid fluid / Electrolyte replacement solution |
| Modality | Small molecule |
| Therapeutic area | Fluid and Electrolyte Management |
| Phase | FDA-approved |
Mechanism of action
This solution contains sodium and chloride ions in concentrations (0.9% w/v) that are isotonic with human blood plasma, preventing osmotic shifts across cell membranes. It is used for fluid replacement, electrolyte supplementation, and as a vehicle for drug administration. The solution does not exert a pharmacological effect but rather serves as a physiological support agent.
Approved indications
- Fluid and electrolyte replacement in dehydration
- Vehicle for intravenous drug administration
- Maintenance of vascular access patency
- Perioperative fluid management
Common side effects
- Hyperchloremic acidosis (with prolonged or excessive use)
- Fluid overload / Hypervolemia
- Hypokalemia (with chronic use without potassium supplementation)
- Local phlebitis at infusion site
Key clinical trials
- A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma (PHASE3)
- Modified Autologous Leukocyte Cells for the Treatment of Acute Kidney Injury After Cardiac Surgery (PHASE2)
- Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure (PHASE3)
- Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns (PHASE2, PHASE3)
- Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders (PHASE1)
- A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion (NA)
- To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products (NA)
- Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isotonic sodium chloride 0.9 percent CI brief — competitive landscape report
- Isotonic sodium chloride 0.9 percent updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI