PACKAGE LABEL– Sodium Lactate Ringer-500 mL Bag Label

INDICATIONS

Regulating body fluids, electrolytes and acid-base balance regulating drugs. For metabolic acidosis or dehydration cases with metabolic acidosis.

CONTRAINDICATION

The following conditions should be contraindicated:

• Heart failure and acute pulmonary edema;
• Cerebral edema;
• Lactic acidosis;
• Severe hepatic insufficiency;
• Severe renal failure oliguria or anuria;
• Hyperkalemia;
• Severe burn;
• Addison's disease.

ADVERSE REACTIONS

• Patients with hypocalcemia (such as uremia) are prone to numbness, pain, twitching, dyspnea and other symptoms after correcting acidosis, which are often caused by the decrease of calcium ion concentration in the blood;
• Accelerated heart rate, chest tightness, shortness of breath and other pulmonary edema, heart failure;
• Elevated blood pressure;
• Weight gain, edema;
• Alkalosis occurs when overdose;
• The concentration of blood potassium decreases, and sometimes hypokalemia appears.

DRUG INTERACTIONS

When combined with other drugs, pay attention to the incompatibility of drugs (such as macrolide antibiotics, alkaloids, sulfonamides) due to changes in pH and ionic strength. Because this product contains calcium ions, it will precipitate when mixed with blood containing sodium citra

OTHER INFORMATION

[Package]

Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to break apart , double valve and double plug). 500ml/ bag, 1000ml/ bag.

[Validity] 24 months

**[Executive standard]**Pharmacopoeia of the People's Republic of China (2020, Volume II)

[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

SPECIFICATION

• 500ml
• 1000ml: Sodium lactate 3.10g, sodium chloride 6.00g, potassium chloride 0.30g, calcium chloride 0.20g.

DOSAGE AND USAGE

Intravenous drip. Adult 500ml ~ 1000ml at a time, according to age weight and symptoms can be appropriate to increase or decrease. Administration speed: 300 ~ 500ml per hour for adults.

PRECAUTIONS

The following cases should be used with caution:

• Diabetic patients taking biguanides (especially hypoglycemic), hinder the liver's utilization of lactic acid, easy to cause lactic acid poisoning;
• Edema patients with a tendency to sodium retention;
• Hypertension patients can increase blood pressure;
• Heart dysfunction;
• The rate of lactic acid degradation is slowed down when liver function is not complete, so as to delay the correction speed of acidosis;
• Hypoxia and shock, insufficient tissue blood supply and hypoxia when lactic acid oxidation into pyruvate into tricarboxylic acid cycle metabolism slowed down, so as to delay the correction speed of acidosis;
• Alcoholism, salicylic acid poisoning, type I glycogen deposition disease have lactic acidosis tendency, it is not appropriate to use sodium lactate to correct the acid-base balance;
• When diabetic ketoacidosis acetoacetic acid, β-hydroxybutyric acid and lactic acid are increased, and often accompanied by poor circulation or insufficient blood supply of organs, lactic acid degradation rate is slowed down;
• Renal insufficiency, prone to water and sodium retention, increase cardiovascular load.

The following tests and observations should be made during medication:

• Blood pH and/or carbon dioxide binding force;
• Serum sodium, potassium, calcium, chlorine concentration determination;
• Determination of renal function, including creatinine, urea nitrogen, etc.;
• Blood pressure;
• Cardiopulmonary function status, such as edema, shortness of breath, cyanosis, pulmonary rale, jugular vein filling, hepato-jugular vein regurgitation, venous pressure or central venous pressure measurement as needed;
• Liver insufficiency performance jaundice, change of mind, ascites, etc., applied before and after sodium lactate and in the application process, often observed at any time.

MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN

Pregnant women with gestational poisoning may aggravate edema, increase blood pressure, should be used with caution.

MEDICATION IN CHILDREN

The dosage should be calculated according to age, weight and condition.

MEDICATION IN THE ELDERLY

Elderly patients often have hidden cardiac and renal insufficiency, which should be used with caution.

DRUG OVERDOSE

An overdose may result in edema or ion imbalance in the body.

PHARMACOLOGY AND TOXICOLOGY

This product can regulate body fluid volume and osmotic pressure, and can supplement potassium, sodium, calcium and chloride ions. Among them, sodium lactate is converted into bicarbonate ion in the body to regulate acid-base balance and maintain normal physiological functions; Na＋is the most important cation in extracellular fluid, which is the main substance for maintaining constant osmotic pressure and extracellular volume of body fluid. K＋is the main intracellular cation, which plays an important role in maintaining normal neuromuscular excitability. As a second messenger in the cell, calcium ion is closely related to many functions in the body. Lactate ions can correct metabolic acidosis and allow potassium ions to enter the cell from blood and extracellular fluid. When the amount of circulating blood and interstitial fluid in the body is reduced, this product can be used as a supplementary regulator of interstitial fluid, and has a corrective effect on electrolyte disturbance and acidosis.

PHARMACOKINETICS

This experiment has not been performed and no reliable references are available.

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.

STORAGE

Sealed storage.

HEALTH CARE PROVIDER LETTER pg.3