DESCRIPTION
id: 66ffab95-b721-424a-acdf-02f406ce9263
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sodium Chloride Injection, USP 0.9%, is a sterile, nonpyrogenic, isotonic solution. Each mL contains Sodium Chloride 9 mg, Water for Injection q.s. pH (range 4.5 – 7.0) adjusted with Hydrochloric Acid and/or Sodium Hydroxide when necessary. Preservative Free.
CLINICAL PHARMACOLOGY
id: 4ceab70b-5153-4874-a5ae-3eecb4c2432c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. Sodium (Na+) is the principal 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.
INDICATIONS AND USAGE
id: c7735cbb-7e18-45a1-aa97-f36ec3458d07
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
CONTRAINDICATIONS
id: 402e0462-693d-4e5f-97f3-ad084c4df4e4
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
None known.
WARNINGS
id: 25ff37dd-9ab9-4c24-8d67-cba4f4cca619
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Excessive amounts of Sodium Chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention.
PRECAUTIONS
id: c6e6aeda-3685-48d6-87ec-1e8c975c9ebb
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
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 corticotropin.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
ADVERSE REACTIONS
id: 76025ee5-f7e8-41a0-980c-97fcd3ab955b
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
OVERDOSAGE
id: e75e46fb-df10-4fcc-b44f-ae5c06a9c63b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
In the event of overhydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (See WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.)
DOSAGE AND ADMINISTRATION
id: 69fc7bff-2d26-4f4a-94d1-1ced672b5efd
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The dose is dependent upon the age, weight and clinical condition of the patient.
Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.
HOW SUPPLIED
id: 31acccae-ed6f-415b-8173-472af7056622
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sodium Chloride Injection, USP 0.9%
NDC 0517-2802-25 2 mL Single Dose Vials packed in boxes of 25.
NDC 0517-2810-25 10 mL Single Dose Vials packed in boxes of 25.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN2802
Rev. 1/09
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Container
id: 421b19a5-4c44-409f-a5cc-9eea7092a06f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0517-2810-25
SODIUM CHLORIDE
INJECTION, USP
0.9%
10 mL
SINGLE DOSE VIAL
FOR DRUG DILUENT USE
PRESERVATIVE FREE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Carton
id: d918775c-4519-4f8c-a313-99c9c19d9537
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
SODIUM CHLORIDE
INJECTION, USP
0.9%
NDC 0517-2810-25
25 x 10 mL
SINGLE DOSE VIALS
FOR DRUG DILUENT USE
PRESERVATIVE FREE
Rx Only
Each mL contains: Sodium Chloride 9 mg, Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
0.3 mOsmol/mL. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20°-25°C (68°-77°F);excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
