SODIUM CHLORIDE 0.9%- sodium chloride injection, solution

SODIUM CHLORIDE 0.9% by

Drug Labeling and Warnings

SODIUM CHLORIDE 0.9% by is a Prescription medication manufactured, distributed, or labeled by Huaren Pharmaceutical (Rizhao) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

CHARACTER

This product is a colorless and clear liquid.

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:

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

Follow-up examination:

1. CD Serum sodium, potassium, chlorine concentration
2. Blood acid-base balance index
3. Kidney function
4. Blood pressure
5. 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

1. 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.
2. 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

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

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

OTHER INFORMATION

[EXECUTIVE STANDARD]

Pharmacopoeia of the People's Republic of China (2020, Volume 11)

[APPROVAL NUMBER]

GuoYaoZhunZi: H20033208 (50ml: 0.45g)

GuoYaoZhunZi: H20023682 (100ml: 0.9g)

GuoYaoZhunZi: H20023146 (250ml: 2.25g)

GuoYaoZhunZi: H20023145 (500ml: 4.5g)

GuoYaoZhunZi: H20023750 (1000ml: 9g)

[PHARMACEUTICAL MARKETING AUTHORIZATION HOLDER]

Name: Huaren Pharmaceutical Co., Ltd.

Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China.

[MANUFACTURER]

Enterprise Name: Huaren Pharmaceutical Co., Ltd.

Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101

Tel.: 400-0648885

Fax: 0532-67709071

Website: http//www.qdhuaren.com

Fax: 0532-88702625

HEALTH CARE PROVIDER LETTER pg.1

HEALTH CARE PROVIDER LETTER pg.2

HEALTH CARE PROVIDER LETTER pg.3

PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag Label

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 0.9% 
sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85268-801
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85268-801-03	10 in 1 CASE	03/07/2025
1	NDC: 85268-801-02	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		03/07/2025

Labeler - Huaren Pharmaceutical (Rizhao) Co., Ltd. (527866378)