0.9% SODIUM CHLORIDE INJECTION
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sodium chloride injection, powder, for solution
Fresenius Medical Care North America
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0.9% Sodium Chloride Injection, USP Flexible Plastic Container0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is a parenteral solution containing solution chloride in water for injection for intravenous administration.
Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium chloride in water for injection. Electrolytes per 1000 mL: sodium (Na+) 154 mEq; chloride (Cl-) 154 mEq. The osmolarity is 308 mOsmol/L (calc).
The pH is 5.6 (4.5 - 7.0).
This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required, the unused portion should be discarded.
0.9% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher.
Sodium Chloride Injection, USP is chemically designated NaCl, a white crystalline power freely soluble in water.
Water for Injection, USP is chemically designed H2O.
The flexible plastic inner bag is fabricated from a specially compounded polyvinylchloride. Water may permeate through the inner bag into the outerwrap in quantities insufficient to significantly affect the solution. Solutions in contact with the plastic inner bag can leach out certain of its chemical components in very small amounts; however, the safety of the plastic formulation is supported by biological testing.
Exposure to temperatures above 25oC (77oF) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
When administered intravenously, these solutions provide a source of water and electrolytes.
Solutions which provide combinations of hypotonic or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements.
Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome.
Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principle cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidney which maintains a balance between intake and output.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
None known.
Solutions containing sodium ions should be used with great care, if it all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
Excessive administration of potassium-free solutions may result in significant hypokalemia.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states of pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotrophin.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility.
Pregnancy:
Teratogenic Effects
Pregnancy Category C. Animal reproductive studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing women.
Pediatric Use:
Code | Product Name | Container Size (mL) | NDC |
060-10109 | 0.9% Sodium Chloride Injection, USP | 1000 | 46163-300-10 |
0.9% SODIUM CHLORIDE INJECTION
sodium chloride injection, powder, for solution |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA078177 | 04/12/2007 |
Labeler - Fresenius Medical Care North America (075684324) |
Registrant - Fresenius Medical Care North America (075684324) |