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Normale Saline Solution
Normal saline solution provides isotonic fluid replacement and electrolyte balance by delivering 0.9% sodium chloride in water to match physiological osmolarity.
Normal saline solution provides isotonic fluid replacement and electrolyte balance by delivering 0.9% sodium chloride in water to match physiological osmolarity. Used for Fluid resuscitation and volume replacement in dehydration, Maintenance of electrolyte balance in hospitalized patients, Vehicle for intravenous drug administration.
At a glance
| Generic name | Normale Saline Solution |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Crystalloid fluid / Electrolyte replacement solution |
| Modality | Small molecule |
| Therapeutic area | Critical Care / Fluid and Electrolyte Management |
| Phase | Phase 3 |
Mechanism of action
Normal saline (0.9% NaCl) is an isotonic crystalloid solution that maintains osmotic balance with blood plasma, preventing cell lysis or crenation. It is used to restore intravascular volume, maintain electrolyte homeostasis, and serve as a vehicle for drug delivery. The solution contains sodium and chloride ions at physiological concentrations (approximately 154 mEq/L each).
Approved indications
- Fluid resuscitation and volume replacement in dehydration
- Maintenance of electrolyte balance in hospitalized patients
- Vehicle for intravenous drug administration
Common side effects
- Hyperchloremic acidosis
- Fluid overload / pulmonary edema
- Hypokalemia
- Phlebitis at infusion site
Key clinical trials
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) (PHASE3)
- Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO) (PHASE3)
- Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease (PHASE3)
- Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support (PHASE4)
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:
- Normale Saline Solution CI brief — competitive landscape report
- Normale Saline Solution updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI