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Normal Saline 0.9% Infusion Solution Bag
Normal saline provides isotonic fluid replacement to maintain hydration and electrolyte balance.
Normal Saline 0.9% Infusion Solution Bag, marketed by Vanderbilt University Medical Center, is a widely used intravenous fluid in clinical settings. The key composition patent is set to expire in 2028, providing a period of exclusive protection. The primary risk is the potential increase in competition post-patent expiry.
At a glance
| Generic name | Normal Saline 0.9% Infusion Solution Bag |
|---|---|
| Also known as | Normal Saline, sodium chloride 0.9% infusion solution bag |
| Sponsor | Vanderbilt University Medical Center |
| Drug class | Crystalloid fluid / Electrolyte replacement solution |
| Modality | Small molecule |
| Therapeutic area | Critical Care / Fluid and Electrolyte Management |
| Phase | FDA-approved |
Mechanism of action
Normal saline (0.9% sodium chloride) is an isotonic crystalloid solution that matches the osmolarity of blood plasma. It is used intravenously to restore intravascular volume, maintain electrolyte homeostasis, and serve as a vehicle for medication delivery. The solution contains 0.9 g/100 mL of sodium chloride, providing 154 mEq/L each of sodium and chloride ions.
Approved indications
- Fluid resuscitation and maintenance in dehydration
- Perioperative fluid replacement
- Vehicle for intravenous medication administration
- Treatment of hypovolemia and shock
Common side effects
- Hyperchloremic acidosis
- Fluid overload / pulmonary edema
- Hypernatremia
- Phlebitis at infusion site
Key clinical trials
- Stem Cells for Erectile Dysfunction Post RALP (PHASE1, PHASE2)
- Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (PHASE3)
- TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study (PHASE4)
- Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery (NA)
- Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) (PHASE3)
- OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis (PHASE1)
- The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma (PHASE3)
- Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors (PHASE2)
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
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