0.9% sodium chloride injection

[Drug Name]

 Generic name: Sodium Chloride Injection

 English Name: Sodium Chloride  Injection

Chinese Pinyin: Lühuana Zhusheye

【Certificate    】

 The main ingredient of this product is sodium chloride, its chemical name: sodium chloride.

 Chemical structure: NaCl

 Molecular formula: NaCl

 Molecular weight: 58.44

 Auxiliary material name: Water for injection.

【Sex    Condition】This product is a colorless, clear liquid.

【Indications】

 Dehydration caused by various reasons, including hypotonic, isotonic, and hypertonic dehydration; hypertonic non-ketotic diabetic coma can be corrected with isotonic or hypotonic sodium chloride to address dehydration and hypertonic status; hypochloremic metabolic alkalosis; external use of saline for eye washing, wound cleansing, etc.; also used for amniotic sac induction in obstetrics.

【Specifications】    (1)500ml:4.5g  (2)250ml:2.25g  (3)100ml:0.9g

[Adverse Reactions]

 (1)  Excessive or rapid infusion can lead to water and sodium retention, causing edema, elevated blood pressure, increased heart rate, chest tightness, difficulty breathing, and even acute left heart failure.

 (2)  Excessive and rapid administration of hypotonic sodium chloride can lead to hemolysis, cerebral edema, and other complications.   

【禁    忌】尚不明确。 

[Precautions]

(1)Please check carefully before use. If the solution is cloudy, contains foreign objects, has changed color, or if the bottle is cracked or damaged, or if the neck interface and cap are not securely welded, do not use; once this product has been used, do not store the remaining solution for reuse; when puncturing the rubber stopper, please apply vertical and even force within the specified range (center of the circle or center of the concave circle).

 (2)Use with caution in the following situations:

 ①Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, cerebral edema, and idiopathic edema; ②Acute renal failure during the oliguria phase, and chronic renal failure with reduced urine output that responds poorly to diuretics;

 ③Hypertension; ④Hypokalemia.   

 (3)According to clinical needs, check the concentrations of sodium, potassium, and chloride ions in the serum; indicators of acid-base balance in the blood, kidney function, as well as blood pressure and cardiopulmonary function. 

[Medication for Pregnant and Breastfeeding Women] Hypertensive disorders in pregnancy are contraindicated.   

[Pediatric Medication] The amount and speed of fluid replacement should be strictly controlled. 

[Medication for the Elderly] The amount and speed of fluid replacement should be strictly controlled. 

【Drug Interactions】 When used as a solvent or diluent for drugs, attention should be paid to the compatibility contraindications between drugs.   

[Drug overdose] can lead to hypernatremia and hypokalemia, and can cause bicarbonate loss.

【Pharmacology and Toxicology】

 Sodium chloride is an electrolyte supplement medication. Sodium and chloride are important electrolytes in the body, primarily found in extracellular fluid, playing a crucial role in maintaining the normal volume and osmotic pressure of blood and extracellular fluid. The normal serum sodium concentration is 135-145mmol/L , accounting for 92% of plasma cations and 90% of total osmotic pressure, thus the plasma sodium amount plays a decisive role in osmotic pressure. The normal serum chloride concentration is 98-106mmol/L , and sodium and chloride ions in the human body are mainly regulated by the hypothalamus, posterior pituitary, and kidneys to maintain the stability of fluid volume and osmotic pressure.

Pharmacokinetics

 Sodium chloride, after intravenous injection, directly enters the bloodstream and is widely distributed in the body, but is mainly present in extracellular fluid. Sodium ions and chloride ions can be filtered by the glomeruli and are partially reabsorbed by the renal tubules. They are excreted by the kidneys with urine, with only a small portion being excreted through sweat.

【Storage】Keep in a sealed container.

【Packaging】Polypropylene infusion bottles    500ml×30 bottles/box   250ml×40 bottles/box   250ml×50 bottles/box

100ml×100bottles/box   100ml×120bottles/box             

【Validity Period】24 months 

[Implementation Standard] 'Pharmaceutical Standards of China' 2020 Edition Volume Two

Approval Number

【Drug Marketing Authorization Holder】/【Manufacturing Enterprise】

Name    : Guizhou Tiandi Pharmaceutical Co., Ltd.

Address: No. 6 Baokang Road, Hongxing Pharmaceutical Industry Park, Dingxiao Town, Xingyi City, Qiannan Buyei and Miao Autonomous Prefecture, Guizhou Province6

 Postal Code: 562400

 Phone number: 0859-3119928

 Fax number: 0859-3118152

 Website: www.gztiandi.com