{"adverse_reactions":["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."],"clinical_pharmacology":["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."],"description":["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.","SPECIFICATION 50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g"],"dosage_and_administration":["DOSAGE AND USAGE Intravenous infusion, dosage according to the need of the disease."],"drug_interactions":["DRUG INTERACTIONS Should not be used with drugs with known incompatibility contraindications."],"effective_time":"20251107","geriatric_use":["MEDICATION IN THE ELDERLY The amount and speed of fluid supplementation should be strictly controlled."],"health_care_provider_letter":["HEALTH CARE PROVIDER LETTER pg.1 HEALTH CARE PROVIDER LETTER pg.1","HEALTH CARE PROVIDER LETTER pg.2 HEALTH CARE PROVIDER LETTER pg.2","HEALTH CARE PROVIDER LETTER pg.3 HEALTH CARE PROVIDER LETTER pg.3"],"how_supplied":["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."],"id":"43066646-3aaa-8eb7-e063-6394a90a8afc","indications_and_usage":["INDICATIONS It is used to regulate the balance of water and electrolytes in the body."],"openfda":{},"overdosage":["DRUG OVERDOSE For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis."],"package_label_principal_display_panel":["PACKAGE LABEL – 0.9% Sodium Chloride 1000 mL Bag Label PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag","PACKAGE LABE L– 0.9% Sodium Chloride 500 mL Bag Label PACKAGE LABEL– 0.9% Sodium Chloride 500 mL Bag","PACKAGE LABEL – 0.9% Sodium Chloride 250 mL Bag Label PACKAGE LABEL– 0.9% Sodium Chloride 250 mL Bag","PACKAGE LABEL – 0.9% Sodium Chloride 100 mL Bag Label PACKAGE LABEL– 0.9% Sodium Chloride 100 mL Bag","PACKAGE LABEL – 0.9% Sodium Chloride 50 mL Bag Label PACKAGE LABEL– 0.9% Sodium Chloride 50 mL Bag"],"pediatric_use":["MEDICATION IN CHILDREN The amount and speed of fluid supplementation should be strictly controlled."],"pharmacokinetics":["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."],"precautions":["PRECAUTIONS Use with caution in the following cases: 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: Serum sodium, potassium, chlorine concentration; Blood acid-base balance index; Kidney function; Blood pressure and cardiopulmonary function."],"pregnancy":["MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN Not clear."],"set_id":"33648718-2fbc-6840-e063-6294a90a5065","spl_product_data_elements":["SODIUM CHLORIDE 0.9% SODIUM CHLORIDE WATER SODIUM CHLORIDE SODIUM CATION CHLORIDE ION"],"spl_unclassified_section":["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.","CHARACTER This product is a colorless and clear liquid.","VALIDITY The product of 50ml,100ml, and 1000ml specifications is valid for 24 months. The validity period of 250ml,500ml is 36 months.","OTHER INFORMATION [EXECUTIVE STANDARD] Pharmacopoeia of the People's Republic of China (2020, Volume II) [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 0532-67709071 Fax: 0532-88702625 Website: http//www.qdhuaren.com"],"storage_and_handling":["STORAGE Sealed storage."],"version":"3"}