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  5. Label Information: Sodium Chloride 0.9%

FDA Label for Sodium Chloride 0.9%

View Indications, Usage & Precautions

Table of Contents

    1. SODIUM CHLORIDE INJECTION, USP BAG
    2. INGREDIENTS
    3. CHARACTER
    4. INDICATIONS
    5. SPECIFICATION
    6. DOSAGE AND USAGE
    7. ADVERSE REACTIONS
    8. PRECAUTIONS
    9. MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN
    10. MEDICATION IN CHILDREN
    11. MEDICATION IN THE ELDERLY
    12. DRUG INTERACTIONS
    13. DRUG OVERDOSE
    14. PHARMACOLOGY AND TOXICOLOGY
    15. PHARMACOKINETICS
    16. PACKAGE
    17. VALIDITY
    18. STORAGE
    19. OTHER INFORMATION
    20. HEALTH CARE PROVIDER LETTER PG.1
    21. HEALTH CARE PROVIDER LETTER PG.2
    22. HEALTH CARE PROVIDER LETTER PG.3
    23. PACKAGE LABEL– 0.9% SODIUM CHLORIDE 1000 ML BAG LABEL

Sodium Chloride 0.9% Product Label

The following document was submitted to the FDA by the labeler of this product Huaren Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Sodium Chloride Injection, Usp Bag



Sodium Chloride Injection Instructions

Please read the instructions carefully and use under the guidance of a physician.

Check carefully before use. Do not use if leakage is found, the drug liquid is unclear, or there are visible particles, do not use.


Ingredients



This product is an isotonic sterilizing aqueous solution of sodium chloride.

Chemical Name: Sodium chloride

Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg.


Indications



It is used to regulate the balance of water and electrolytes in the body.


Specification



50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g


Dosage And Usage



Intravenous infusion, dosage according to the need of the disease.


Adverse Reactions



Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure.


Precautions



Use with caution in the following cases:

  • CD Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic edema
  • Acute renal failure, oliguria stage, chronic renal failure, urine volume decreased, and poor response to diuretic drugs
  • Hypertension
  • Hypokalemia

    • Follow-up examination:

    • CD Serum sodium, potassium, chlorine concentration
    • Blood acid-base balance index
    • Kidney function
    • Blood pressure
    • Cardiopulmonary function

Medication In Pregnant Women And Lactating Women



Not clear.


Medication In Children



The amount and speed of fluid supplementation should be strictly controlled.


Medication In The Elderly



The amount and speed of fluid supplementation should be strictly controlled.


Drug Interactions



Should not be used with drugs with known incompatibility contraindications.


Drug Overdose



For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis.


Pharmacology And Toxicology



Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure.


Pharmacokinetics



In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys.


Package



  • Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 10O0ml/ bag.
  • Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.


Validity



  • The product of 50ml,100ml, and 1000ml specifications is valid for 24 months.
  • The validity period of 250ml,500ml is 36 months.

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